Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01765153
Other study ID # Pro00003873
Secondary ID
Status Completed
Phase N/A
First received November 30, 2012
Last updated December 17, 2014
Start date March 2008
Est. completion date September 2012

Study information

Verified date December 2014
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review CommitteeCanada: Canadian Institutes of Health Research
Study type Interventional

Clinical Trial Summary

The objective of the study was to determine the efficacy of two forms of physical therapy training, one emphasizing precise, visually guided walking over obstacles and on targets (Precision Training), the other emphasizing mass practice of walking on a treadmill (Endurance Training). The hypothesis was that visually guided training (Precision) may be especially efficacious because it engages the motor cortex, whose input may facilitate improvements in functional walking. Participants are individuals with a chronic (≥7 months post-injury), motor incomplete spinal cord injury (SCI), with no other problems that would preclude participation in an intensive training program. A randomized, single-blinded, cross-over design was used to randomly allocate participants to start with Precision or Endurance Training, identified as Training Phase I. Training was 5x/wk for 2 months, followed by a 2-month rest period, identified as Rest Period I. Participants then returned for 2-months of training in the other method, identified as Training Phase II, followed by another 2-month rest, Rest Period II. Measures of walking speed, distance, skill, confidence, as well as depression were obtained at least 3 times before any training, then monthly thereafter. Electrophysiological measures were taken before and after each phase of training and period of rest. Change scores were used to determine how each phase of training and rest influenced the scores (see below).


Description:

PARTICIPANTS: Inclusion criteria: 1) SCI from trauma or other stable lesions, 2) injury occurred ≥ 7 mo prior, 3) able to walk independently at least 5 m with a walking aid and/or braces, 4) injury level between C1-L1, 5) able to give informed consent, 6) able to attend training sessions 5x/week. Exclusion criteria: 1) head injury, 2) cognitive or musculoskeletal impairments that preclude participation in walking training, 3) seizures or implants in the head that would preclude participation in experiments using transcranial magnetic stimulation (TMS).

INTERVENTIONS:

Precision Training. Training was performed on a 15 m long track. The track contained obstacles and targets. Obstacles were made of Styrofoam blocks of 3 cm height each, varying in width from 4 cm to 20 cm in divisions of 4 cm increments (which must be cleared without touching), and targets were made of fabric circles, ranging in diameter from 7-10.5 cm (which must be totally obscured by their foot). The difficulty of the track was designed to have the participant achieve ~80% success. The emphasis was on accuracy, not speed.

Endurance Training. The aim of this training was mass practice. Participants walked on the treadmill, with body-weight support (BWS) and manual assistance if needed. The treadmill speed was initially set to be faster than their over ground walking speed as measured by the 10 MWT(ss). Participants were encouraged to walk for as far and as fast as possible with minimal rest periods. Progression involved reducing manual assistance and BWS, increasing walking speed and distance, while reducing rest breaks.

In both phases of training, a research assistant or volunteer recorded training parameters each session. The number of steps executed was measured with a step counter (StepWatch, Orthocare Innovations, USA), which was confirmed to be accurate with simultaneous manual counting prior to its use, and periodically during training sessions. The heart rate before and immediately after each bout of walking was measured with a heart rate monitor (Polar FT7, Polar, Canada). The total time, distance and walking speed for each walking bout was recorded.

MEASURES:

Measures were taken prior to all training at baseline (called Baseline I) and the end of each of the following intervals - one month of Training Phase I, two months of Training Phase I, one month of Rest Period I, two months of Rest Period I, one month of Training Phase II, two months of Training Phase II, one month of Rest Period II, two months of Rest Period II. To measure changes during the second phase of training, the baseline was the average of the one and two month measures of Rest Period I, henceforth called Baseline II.

STATISTICAL ANALYSIS: To determined if one type of training was superior to the other, we compared the change scores (i.e., post-training score minus pre-training score) from each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. Since individuals with high compared to low walking function may respond to the training differently, we divided individuals based on their pretraining walking speed as measured by the 10 MWT(ss) (i.e., > or < 0.5 m/s). The change scores from each of these groups of individuals were then compared for each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. To determine the time course for obtaining a treatment effect, we compared the change scores for the first month (i.e., outcome measure at end of 1 mo minus baseline) versus the second month (outcome measure at end of 2 mo minus at end of 1 mo) of training for each type of training, using a standard t-test or a Mann-Whitney U test, as appropriate. Retention of gains was followed for 2 months after each type of training. The outcome measures at the end of the 2 month rest period were compared to the measures immediately after the training, for individuals that made improvements greater than the standard error of measurement for each measure, using a paired t-test or Wilcoxon signed-rank test, as appropriate.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- spinal cord injury equal or more than 7 months prior

- able to walk at least 5 meters independently (can use walking aids and braces)

- injury level between C1 and L1

- able to give informed consent

- able to attend training sessions 5x/week

Exclusion Criteria:

- head injury

- cognitive of musculoskeletal impairments that preclude participation in walking training

- seizures or implants in the head that would preclude participation in experiments with transcranial magnetic stimulation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Endurance
Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training.
Precision
Participants train daily to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto.

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Alberta Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures for all 7 items. Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study) No
Secondary Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 1 month of Training Phase I This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures. Change from Baseline I to 1 month of Training Phase I No
Secondary Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 months of Training Phase I This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the end of 2 months of Rest Period I This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 1 month of Training Phase II This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures. Change from Baseline II to 1 month of Training Phase II No
Secondary Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 months of Training Phase II This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the end of 2 months of Rest Period II This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in 6 Minute Walk test (6MWT) at 1 month of Training Phase I Participants walk for as far as possible in 6 min along a 25m hallway. Change from Baseline I to 1 month of Training Phase I No
Secondary Change in 6 minute walk test (6MWT) at 2 months of Training Phase I Participants walk for as far as possible in 6 min along a 25m hallway. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in 6 minute walk test (6MWT) at the end of 2 months of Rest Period I Participants walk for as far as possible in 6 min along a 25m hallway. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in 6 minute walk test (6MWT) at 1 month of Training Phase II Participants walk for as far as possible in 6 min along a 25m hallway. Change from Baseline II to 1 month of Training Phase II No
Secondary Change in 6 minute walk test (6MWT) at 2 months of Training Phase II Participants walk for as far as possible in 6 min along a 25m hallway. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in 6 minute walk test (6MWT) at the end of 2 months of Rest Period II Participants walk for as far as possible in 6 min along a 25m hallway. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at 1 month of Training Phase I Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed. Change score from Baseline I to 1 month of Training Phase I No
Secondary Change in 10 metre walk test at a self-selected speed [10MWT(ss)] at 2 months of Training Phase I Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at the end of 2 months of Rest Period I Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at 1 month of Training Phase II Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed. Change from Baseline II to 1 month of Training Phase II No
Secondary Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at 2 months of Training Phase II Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at the end of 2 months of Rest Period II Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in 10 meter walk test at fastest safe speed [10MWT(f)] at 1 month Training Phase I Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed. Change from Baseline I to 1 month of Training Phase I No
Secondary Change in 10 meter walk test at a fast speed [10MWT(f)] at 2 months of Training Phase I Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in 10 meter walk test at a fast speed [10MWT(f)] at the end of 2 months of Rest Period I Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in 10 meter walk test at a fast speed [10MWT(f)] at 1 month of Training Phase II Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed. Change from Baseline II to 1 month of Training Phase II No
Secondary Change in 10 meter walk test at a fast speed [10MWT(f)] at 2 months of Training Phase II Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in 10 meter walk test at a fast speed [10MWT(f)] at the end of 2 months of Rest Period II Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at 1 month of Training Phase I Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.). Change from Baseline I to 1 month of Training Phase I No
Secondary Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at 2 months of Training Phase I Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.). Change from Baseline I to 2 months of Training Phase I No
Secondary Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at the end of 2 months of Rest Period I Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.). Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at 1 month of Training Phase II Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.). Change from Baseline II to 1 month of Training Phase II No
Secondary Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at 2 months of Training Phase II Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.). Change from Baseline II to 2 months of Training Phase II No
Secondary Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at the end of 2 months of Rest Period II Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.). Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in Walking Index for Spinal Cord Injury version II maximum (WISCI-II max) at 1 month of Training Phase I Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale. Change from Baseline I to 1 month of Training Phase I No
Secondary Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at 2 months of Training Phase I Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at the end of 2 months of Rest Period I Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at 1 month of Training Phase II Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale. Change from Baseline II to 1 month of Training Phase II No
Secondary Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at 2 months of Training Phase II Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at the end of 2 months of Rest Period II Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in Activities-specific Balance Confidence Scale (ABC) at 1 month of Training Phase I A survey with 16 questions participants answer using a pen/paper format. Change from Baseline I to 1 month of Training Phase I No
Secondary Change in Activities-specific Balance Confidence Scale (ABC) at 2 months of Training Phase I A survey with 16 questions participants answer using a pen/paper format. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in Activities-specific Balance Confidence Scale (ABC) at the end of 2 months of Rest Period I A survey with 16 questions participants answer using a pen/paper format. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in Activities-specific Balance Confidence Scale (ABC) at 1 month of Training Phase II A survey with 16 questions participants answer using a pen/paper format. Change from Baseline II to 1 month of Training Phase II No
Secondary Change in Activities-specific Balance Confidence Scale (ABC) at 2 months of Training Phase II A survey with 16 questions participants answer using a pen/paper format. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in Activities-specific Balance Confidence Scale (ABC) at the end of 2 months of Rest Period II A survey with 16 questions participants answer using a pen/paper format. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 1 month of Training Phase I A survey filled out by participants using a pen/paper format. Change from Baseline I to 1 month of Training Phase I No
Secondary Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 months of Training Phase I A survey filled out by participants using a pen/paper format. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the end of 2 months of Rest Period I A survey filled out by participants using a pen/paper format. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 1 month of Training Phase II A survey filled out by participants using a pen/paper format. Change from Baseline II to 1 month of Training Phase II No
Secondary Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 months of Training Phase II A survey filled out by participants using a pen/paper format. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the end of 2 months of Rest Period II A survey filled out by participants using a pen/paper format. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in Manual muscle test (MMT) at 2 months of Training Phase I The strength of major muscle groups in the lower extremities, bilaterally (8 groups/side), is tested manually using the standard manual muscle test used in clinics, and a composite single score is calculated. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in Manual muscle test (MMT) at the end of 2 months of Rest Period I The strength of major muscle groups in the lower extremities, bilaterally (8 groups/side), is tested manually using the standard manual muscle test used in clinics, and a composite single score is calculated. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in Manual muscle test (MMT) at 2 months of Training Phase II The strength of major muscle groups in the lower extremities, bilaterally (8 groups/side), is tested manually using the standard manual muscle test used in clinics, and a composite single score is calculated. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in Manual muscle test (MMT) at the end of 2 months of Rest Period II The strength of major muscle groups in the lower extremities, bilaterally (8 groups/side), is tested manually using the standard manual muscle test used in clinics, and a composite single score is calculated. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in cutaneomuscular reflexes at 2 months of Training Phase I Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are recorded in standing. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in cutaneomuscular reflexes at the end of 2 months of Rest Period I Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in cutaneomuscular reflexes at 2 months of Training Phase II Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in cutaneomuscular reflexes at the end of 2 months of Rest Period II Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
Secondary Change in Transcranial magnetic stimulation (TMS) at 2 months of Training Phase I Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs. Change from Baseline I to 2 months of Training Phase I Yes
Secondary Change in Transcranial magnetic stimulation (TMS) at the end of 2 months of Rest Period I Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I Yes
Secondary Change in Transcranial magnetic stimulation (TMS) at 2 months of Training Phase II Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs. Change from Baseline II to 2 months of Training Phase II Yes
Secondary Change in Transcranial magnetic stimulation (TMS) at the end of 2 months of Rest Period II 2 months of Training Phase 2 Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II Yes
Secondary Change in Electromyography during treadmill walking at 2 months of Training Phase I Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees. Change from Baseline I to 2 months of Training Phase I No
Secondary Change in Electromyography during treadmill walking at the end of 2 months of Rest Period I Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees. Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I No
Secondary Change in Electromyography during treadmill walking at 2 months of Training Phase II Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees. Change from Baseline II to 2 months of Training Phase II No
Secondary Change in Electromyography during treadmill walking at the end of 2 months of Rest Period II Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees. Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II No
See also
  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 NCT02161913 - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers N/A
Completed NCT02262234 - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study Phase 1/Phase 2
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 NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT02149511 - Longitudinal Morphometric Changes Following SCI
Completed NCT01025609 - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
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