Spinal Cord Injury Clinical Trial
Official title:
Integrated Tele-exercise for Individuals With SCI: Physical, Psychological, and Social Responses With Spinal Cord Injury
The objective of this study is to examine the efficacy of an integrated, participant-centered tele-health physical activity program for individuals with SCI on psychological and social factors through a parallel mixed-methods design approach. We will examine changes in psychological (self-efficacy, self-esteem, exercise outcome expectations, depression, positive affect and well-being, quality of life) and social factors (participation and satisfaction with social roles and activities, activity engagement) following participation in an 8-week integrated group tele-exercise health and wellness physical activity program, with retention assessed at 8-weeks following completion (16 weeks from baseline). We will also complete small group interviews with all participants to understand participant experiences of, response to, and recommendations before and following participation in group tele-exercise program. To date, there is extremely limited evidence for the efficacy of psychological and social well-being of remotely delivered community-based exercise to individuals with SCI. A pilot effectiveness trial of a tele-exercise health and wellness program will be conducted using a mixed methods design with a randomized waitlist control group. Quantitative and qualitative data collection is sequential in nature and other data are collected simultaneously. Individuals with SCI (living with injury 12 months or longer) will be recruited based on existing partnerships locally and nationally. To assess limited effectiveness, we aim to enroll 35 individuals with SCI. Recruitment of these participants will stem from the investigator's ongoing community partnership with local and national partners. The tele-exercise health & wellness program will consist of virtual group class, twice per week, intended to generate physical confidence and strength for individuals living with SCI. Each session will be co-led with by an individual living with SCI.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | May 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - report a complete or incomplete SCI of ASIA grade A, B, C, or D - living with injury at least 12 months - self-reported ability to elevate shoulder 25% motion - self-report being between 18-75 years of age - self report not currently receiving structured rehabilitation, - cleared by screen by ACSM guidelines for participation - Internet access to participate in virtual classes Exclusion Criteria: - absolute contraindications as identified by ACSM21 - self-report previous hospitalization within a month - self report active pressure ulcer - self report recent osteoporotic fracture - self-report uncorrectable vision loss, - self report preexisting neurological conditions other than SCI |
Country | Name | City | State |
---|---|---|---|
United States | Drexel University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Drexel University | Pennsylvania Department of Health, The Craig H. Neilsen Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in narrative responses from focus group interviews at Week 8 | Semi-structured interviews or small tele-focus groups of 3-5 individuals that will take 60 minutes | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in quality of life rating on the Subjective Quality of Life Questionnaire (SQoL) at Week 8 | This questionnaire is a global measure of subjective perception of QoL. The scale is a Likert-type scale measuring satisfaction with life as a whole: Participants are asked to take everything in their life into account and rate it on an ordinal scale from 1 (life is very distressing; it's hard to imagine how it could get much worse) to 7 (life is great; it's hard to imagine how it could get much better). Test-retest reliability is high (91% agreement), and this questionnaire is validated with the SCI population. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in pain interference on the Spinal Cord Injury Quality of Life - Measurement System-Pain Interference Short Form at Week 8 | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Pain Interference short form is comprised of 10 items, asking participants to rate their pain interference on an ordinal scale from 1 (not at all) to 5 (very much) where a higher sum score represents greater pain interference over the previous 7 days. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in pain behavior on the Spinal Cord Injury Quality of Life Measurement System-Pain Behavior Short Form at Week 8 | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Pain Behavior short form is comprised of 7 items, asking participants to rate their pain behavior on an ordinal scale from 1 (never) to 5 (always) for questions 1-3 and from 1 (had no pain) to 6 (always) in questions 4-7 where a higher sum score represents greater pain behavior over the previous 7 days. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in self-esteem on the Spinal Cord Injury Quality of Life Measurement System-Self-Esteem Short Form at Week 8 | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Self-Esteem short form is comprised of 8 items, asking participants to rate their pain behavior on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents decreased self-esteem with SCI. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form at Week 8 | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Depression short form is comprised of 10 items, asking participants to rate their depressive symptoms on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased despair and/or loss of interest in things with SCI. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in resilience on the Spinal Cord Injury Quality of Life Measurement System-Resilience Short Form at Week 8 | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Resilience short form is comprised of 8 items, asking participants to rate their pain behavior on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased resilience with SCI. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in positive affect and well-being on the Spinal Cord Injury Quality of Life Measurement System-Positive Affect and Wellbeing Short Form at Week 8 | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Positive Affect and Wellbeing short form is comprised of 10 items, asking participants to rate their overall sense of purpose, wellbeing, and life satisfaction on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased positive affect and wellbeing with SCI. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in participation in social roles on the Spinal Cord Injury Quality of Life Measurement System-Participation in Social Roles and Activities Short Form at Week 8 | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Participation in Social Roles and Activities short form is comprised of 10 items, asking participants to rate their current involvement in social roles on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased participation in social roles and activities with SCI. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in satisfaction with social roles on the Spinal Cord Injury Quality of Life Measurement System-Satisfaction with Social Roles and Activities Short Form at Week 8 | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Participation in Social Roles and Activities short form is comprised of 10 items, asking participants to rate their current involvement in social roles on an ordinal scale from 1 (not at all) to 5 (very much) where a higher sum score represents increased satisfaction with social roles and activities with SCI. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in sleep disturbance on the General Sleep Disturbance Scale at Week 8 | The GSDS is a 21-item scale was designed to evaluate the incidence and nature of sleep disturbances. Questions pertain to a variety of general sleep issues, including problems initiating sleep, waking up during sleep, waking too early from sleep, quality of sleep, quantity of sleep, fatigue and alertness at work, and the use of substances to induce sleep. Internal consistency for the full scale has been shown to be 0.88. The GSDS queries respondents regarding the frequency with which they've experienced certain sleep difficulties within the previous week. Respondents use an eight-point, Likert-type scale ranging from 0 (meaning "never") to 7 ("every day") to respond to each item where higher sum score represents increased general sleep disturbance. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in exercise self-efficacy on the Exercise Self-Efficacy Scale at Week 8 | This self-report measures the construct of self-efficacy, or personal beliefs in one's capabilities relating to exercise participation in individuals with SCI. Self-efficacy is cited as the most critical personal factor to behavior change. This outcome demonstrates reliability and high internal consistency. Respondents answer using a 4-point Likert-type scale ranging from 1 (not at all true) to 4 (exactly true) to respond to 10-items where higher sum score represents increased exercise self-efficacy with SCI. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 8 | The Multidimensional Outcome Expectations for Exercise Scale (MOEES). This self-report measure addresses physical, social, and self-evaluative components of outcome expectations, another critical element needed for health behavior change.This tool also demonstrates high internal consistency and validity. Respondents answer using a 5-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree) to respond to 15-items where higher sum score represents increased positive exercise outcome expectations. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Primary | Change in leisure time physical activity behavior on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) at Week 8 | The Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) is an SCI-specific, self-report measure of leisure-time physical activity that assesses minutes of mild, moderate, and heavy intensity leisure-time physical activity performed over the previous 7-days. Test-retest reliability and criterion validity of the LTPAQ-SCI has been established. Total number of exercise minutes over the previous 7-days is calculated. | Pre-Program (0 weeks) and Post-Program (8 weeks) | |
Secondary | Accelerometry | A subset of participants (n=5-10) will receive a wearable activity monitor to be used during a class within weeks 6-8 of the tele-exercise class program. Physical activity monitoring will be performed using one accelerometer (ActiGraph GT3X+) placed on the nondominant wrist of the participant. Participant instruction on use of the accelerometer with occur remotely. Participants can contact the team if they have any issues using the device. Accelerometry data for a one to two 45-minute exercise sessions per participant will be recorded and transformed into minutes of moderate-vigorous physical activity. This will be completed using open-source MIMS unit algorithms based on individually developed thresholds. | One time collection during intervention | |
Secondary | Change in quality of life rating on the Subjective Quality of Life Questionnaire (SQoL) at Week 16 | This questionnaire is a global measure of subjective perception of QoL. The scale is a Likert-type scale measuring satisfaction with life as a whole: Participants are asked to take everything in their life into account and rate it on an ordinal scale from 1 (life is very distressing; it's hard to imagine how it could get much worse) to 7 (life is great; it's hard to imagine how it could get much better). Test-retest reliability is high (91% agreement), and this questionnaire is validated with the SCI population. | Post-Program (8 weeks) and Retention (16 weeks) | |
Secondary | Change in leisure time physical activity behavior on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) at Week 16 | The Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) is an SCI-specific, self-report measure of leisure-time physical activity that assesses minutes of mild, moderate, and heavy intensity leisure-time physical activity performed over the previous 7-days. Test-retest reliability and criterion validity of the LTPAQ-SCI has been established. Total number of exercise minutes over the previous 7-days is calculated. | Post-Program (8 weeks) and Retention (16 weeks) | |
Secondary | Change in exercise self-efficacy on the Exercise Self-Efficacy Scale at Week 16 | This self-report measures the construct of self-efficacy, or personal beliefs in one's capabilities relating to exercise participation in individuals with SCI. Self-efficacy is cited as the most critical personal factor to behavior change. This outcome demonstrates reliability and high internal consistency. Respondents answer using a 4-point Likert-type scale ranging from 1 (not at all true) to 4 (exactly true) to respond to 10-items where higher sum score represents increased exercise self-efficacy with SCI. | Post-Program (8 weeks) and Retention (16 weeks) | |
Secondary | Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 16 | The Multidimensional Outcome Expectations for Exercise Scale (MOEES). This self-report measure addresses physical, social, and self-evaluative components of outcome expectations, another critical element needed for health behavior change.This tool also demonstrates high internal consistency and validity. Respondents answer using a 5-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree) to respond to 15-items where higher sum score represents increased positive exercise outcome expectations. | Post-Program (8 weeks) and Retention (16 weeks) | |
Secondary | Change in quality of life rating on the Subjective Quality of Life Questionnaire (SQoL) from baseline to pre-program (Waitlist control group only) | This questionnaire is a global measure of subjective perception of QoL. The scale is a Likert-type scale measuring satisfaction with life as a whole: Participants are asked to take everything in their life into account and rate it on an ordinal scale from 1 (life is very distressing; it's hard to imagine how it could get much worse) to 7 (life is great; it's hard to imagine how it could get much better). Test-retest reliability is high (91% agreement), and this questionnaire is validated with the SCI population. | Baseline to Pre-Program | |
Secondary | Change in pain interference on the Spinal Cord Injury Quality of Life - Measurement System-Pain Interference Short Form from baseline to pre-program (Waitlist control group only) | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Pain Interference short form is comprised of 10 items, asking participants to rate their pain interference on an ordinal scale from 1 (not at all) to 5 (very much) where a higher sum score represents greater pain interference over the previous 7 days. | Baseline to Pre-Program | |
Secondary | Change in pain behavior on the Spinal Cord Injury Quality of Life Measurement System-Pain Behavior Short Form from baseline to pre-program (Waitlist control group only) | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Pain Behavior short form is comprised of 7 items, asking participants to rate their pain behavior on an ordinal scale from 1 (never) to 5 (always) for questions 1-3 and from 1 (had no pain) to 6 (always) in questions 4-7 where a higher sum score represents greater pain behavior over the previous 7 days. | Baseline to Pre-Program | |
Secondary | Change in self-esteem on the Spinal Cord Injury Quality of Life Measurement System-Self-Esteem Short Form from baseline to pre-program (Waitlist control group only) | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Self-Esteem short form is comprised of 8 items, asking participants to rate their pain behavior on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents decreased self-esteem with SCI. | Baseline to Pre-Program | |
Secondary | Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form from baseline to pre-program (Waitlist control group only) | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Depression short form is comprised of 10 items, asking participants to rate their depressive symptoms on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased despair and/or loss of interest in things with SCI. | Baseline to Pre-Program | |
Secondary | Change in resilience on the Spinal Cord Injury Quality of Life Measurement System-Resilience Short Form from baseline to pre-program (Waitlist control group only) | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Resilience short form is comprised of 8 items, asking participants to rate their pain behavior on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased resilience with SCI. | Baseline to Pre-Program | |
Secondary | Change in positive affect and well-being on the Spinal Cord Injury Quality of Life Measurement System-Positive Affect and Wellbeing Short Form from baseline to pre-program (Waitlist control group only) | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Positive Affect and Wellbeing short form is comprised of 10 items, asking participants to rate their overall sense of purpose, wellbeing, and life satisfaction on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased positive affect and wellbeing with SCI. | Baseline to Pre-Program | |
Secondary | Change in participation in social roles on the Spinal Cord Injury Quality of Life Measurement System-Participation in Social Roles and Activities Short Form from baseline to pre-program (Waitlist control group only) | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Participation in Social Roles and Activities short form is comprised of 10 items, asking participants to rate their current involvement in social roles on an ordinal scale from 1 (never) to 5 (always) where a higher sum score represents increased participation in social roles and activities with SCI. | Baseline to Pre-Program | |
Secondary | Change in satisfaction with social roles on the Spinal Cord Injury Quality of Life Measurement System-Satisfaction with Social Roles and Activities Short Form from baseline to pre-program (Waitlist control group only) | Within the ICF domains of activity and participation, the SCI-QOL measurement system is comprised of 19 item response theory (IRT) calibrated banks/scales across physical, emotional, and social functioning. Each bank is available in a short form (7-10 questions). In clinical or research context, the SCI-QOL is used to document the initial impact of SCI, changes and trajectories of recovery and outcomes of interventions/rehabilitation. The measure demonstrates excellent test-retest reliability (ICC = 0.84). The Participation in Social Roles and Activities short form is comprised of 10 items, asking participants to rate their current involvement in social roles on an ordinal scale from 1 (not at all) to 5 (very much) where a higher sum score represents increased satisfaction with social roles and activities with SCI. | Baseline to Pre-Program | |
Secondary | Change in sleep disturbance on the General Sleep Disturbance Scale from baseline to pre-program (Waitlist control group only) | The GSDS is a 21-item scale was designed to evaluate the incidence and nature of sleep disturbances. Questions pertain to a variety of general sleep issues, including problems initiating sleep, waking up during sleep, waking too early from sleep, quality of sleep, quantity of sleep, fatigue and alertness at work, and the use of substances to induce sleep. Internal consistency for the full scale has been shown to be 0.88. The GSDS queries respondents regarding the frequency with which they've experienced certain sleep difficulties within the previous week. Respondents use an eight-point, Likert-type scale ranging from 0 (meaning "never") to 7 ("every day") to respond to each item where higher sum score represents increased general sleep disturbance. | Baseline to Pre-Program | |
Secondary | Change in exercise self-efficacy on the Exercise Self-Efficacy Scale from baseline to pre-program (Waitlist control group only) | This self-report measures the construct of self-efficacy, or personal beliefs in one's capabilities relating to exercise participation in individuals with SCI. Self-efficacy is cited as the most critical personal factor to behavior change. This outcome demonstrates reliability and high internal consistency. Respondents answer using a 4-point Likert-type scale ranging from 1 (not at all true) to 4 (exactly true) to respond to 10-items where higher sum score represents increased exercise self-efficacy with SCI. | Baseline to Pre-Program | |
Secondary | Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) from baseline to pre-program (Waitlist control group only) | The Multidimensional Outcome Expectations for Exercise Scale (MOEES). This self-report measure addresses physical, social, and self-evaluative components of outcome expectations, another critical element needed for health behavior change.This tool also demonstrates high internal consistency and validity. Respondents answer using a 5-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree) to respond to 15-items where higher sum score represents increased positive exercise outcome expectations. | Baseline to Pre-Program | |
Secondary | Change in leisure time physical activity behavior on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) from baseline to pre-program (Waitlist control group only) | The Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI) is an SCI-specific, self-report measure of leisure-time physical activity that assesses minutes of mild, moderate, and heavy intensity leisure-time physical activity performed over the previous 7-days. Test-retest reliability and criterion validity of the LTPAQ-SCI has been established. Total number of exercise minutes over the previous 7-days is calculated. | Baseline to Pre-Program |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02574572 -
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
|
Phase 1 | |
Recruiting |
NCT05941819 -
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
|
N/A | |
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Recruiting |
NCT02331979 -
Improving Bladder Function in SCI by Neuromodulation
|
N/A | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
Withdrawn |
NCT02237547 -
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02262234 -
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
|
Phase 1/Phase 2 | |
Completed |
NCT02161913 -
Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
|
N/A | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Terminated |
NCT02080039 -
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
|
N/A | |
Completed |
NCT01642901 -
Zoledronic Acid in Acute Spinal Cord Injury
|
Phase 3 | |
Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
Completed |
NCT01471613 -
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02149511 -
Longitudinal Morphometric Changes Following SCI
|
||
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT01025609 -
Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
|
||
Completed |
NCT01086930 -
Early Intensive Hand Rehabilitation After Spinal Cord Injury
|
Phase 3 | |
Terminated |
NCT01005615 -
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A |