Severe Stroke or Similar Neurological Muscle Weakness Clinical Trial
Official title:
Effect of Mobility Training Using Robotic Exoskeletons on Functional Recovery in Individuals With Severe Stroke
| Verified date | January 2024 |
| Source | Shirley Ryan AbilityLab |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the safety and effectiveness of the Ekso robotic exoskeleton in persons affected by a severe stroke. - Primary Objectives: - To determine if a structured high-dosage exoskeleton training program (EXTP) results in clinically significant gains in walking recovery in individuals affected by severe stroke. - To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and severity (non-ambulators vs. limited house-hold ambulators) affects the improvement in gait speed and overall function following the EXTP training protocol. - To determine whether maintenance or further improvement in gait speed can be achieved by an intensive follow-up program of either a traditional rehabilitation program (TRP) or extended EXTP. - Secondary Objectives: - To determine the effect on functional walking endurance as assessed by the 6 minute walk test and 10 meter walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals. - To determine the effect on functional balance, as assessed by the Berg Balance Scale, Functional Gait Assessment and Five times sit to stand measure as assessed by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals. - To determine the effect on stroke recovery, as assessed by the step counter of task specific training in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting
| Status | Active, not recruiting |
| Enrollment | 60 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: - Subjects must be post stroke or have similar neurological weakness (2 weeks up to 6 months post and 6 months or more post) - Subjects must be between 18-85 years of age - Subjects must be able to fit into device and have joint motion to allow ambulation in device - Subjects must be able to tolerate upright standing for 30 minutes - Subjects must have sufficient upper extremity strength and balance to allow ambulation with device - Subjects must have walking speed <0.4m/s, including non-ambulators - Subjects must be able and willing to give written consent and comply with study procedures, including follow-up visits - Mini Mental Status Exam (MMSE) score >17 - Medical clearance from physician Exclusion Criteria: - Subjects must not be shorter than 60 inches or taller than 74 inches - Subjects must not weight greater than 220 lbs - Joint contractures of the hip, knee, or ankle that might limit normal ROM during ambulation - Medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity) - History of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device - Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be able to follow directions and demonstrate learning capability - Pregnancy - Untreated deep vein thrombosis (DVT) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rehabilitation Institute of Chicago | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Shirley Ryan AbilityLab | U.S. Department of Education |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in 6 Minute Walk Test With VO2 Analysis | The 6MWT measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change distance for people with sub-acute stroke is 60.98 meters15. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Primary | Change in 10 Meter Walk Test | This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). The test will be recorded 2 times, with adequate rest in between. The average of the 2 times should be recorded. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Fugl-Meyer Assessment of Motor Recovery After Stroke | The purpose of the FMA is to evaluate and measure recovery in post-stroke hemiplegic patients. There are five domains assessed on a 3 point ordinal scale from 0-2. "0" is equal to "cannot perform", "1" is equal to "performs partially", and "2" is equal to "performs fully. The domain for lower extremity motor function will be used. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Mini Mental Status Examination | The MMSE is a brief screening tool used to provide a quantitative evaluation of cognitive impairment. MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language, and construct ability. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Modified Falls Efficacy Scale | The mFES is a 14 item self-report survey that assesses an individual's perception of balance and stability during indoor and outdoor activities of daily living. The mFES is a 10 point numerical rating scale with higher scores indicating higher confidence in the performance of the activity. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Activities Specific Balance Confidence Scale | The ABC is a 16-item self-report questionnaire that measures confidence in performing various ambulatory activities without falling. Items are rated on a scale ranging from 0-100, with zero representing no confidence and 100 representing complete confidence. It has good to excellent reliability and adequate construct validity, correlating with the BBS and 10mWT. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Community Participation Indicators | The CPI is an eighty-item self-report questionnaire that assesses the individual's satisfaction with their community participation. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Visual Analog Scale | The 0-10 rating scale for pain is used to gain a subjective report of the intensity of a person's pain. Zero represents "no pain" and ten represents "the most intense pain imaginable". A meaningful change would be plus or minus 3 points. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in The Psychosocial Impact Of Assistive Devices Scale | The PIADS is 26 item questionnaires used to assess the impact assistive devices have on the quality of life of an individual who utilizes them. The questionnaire is composed of three subscales: competence, self-esteem, and adaptability. Each item is scored on a 7 point scale with a negative number indicating negative impact and a positive number indicating a positive impact. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Patient Health Questionnaire-9 | The PHQ-9 is a 9-item self-report screening assessment for depression. It is the depression module of the Diagnostic and Statistical Manual (4th edition). Each item is scored from 0-3; total scores may be 0-27, with higher scores representing increased severity of depression. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Stroke Specific Quality of Life | The SSQoL is a self-report questionnaire that is accepted as a reliable and valid way to assess health-related quality of life specific to stroke survivors. Subjects respond to 49 questions in 12 domains: mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality. Each item is rated on a 5-point Likert scale, with higher scores indicating better functioning. Domains scores (un-weighted average of item scores) and a summary score (un-weighted average of all 12 domain scores) are computed. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Range of Motion | Range of motion of the joints of the upper and lower extremities will be measured using a goniometer. | Session 1 (pre test, initial visit) and Session 32 (post test, 10 weeks) | |
| Secondary | Change in Manual Muscle Test | Manual muscle testing is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance. | Session 1 (pre test, initial visit) and Session 10 (post test, 10 weeks) | |
| Secondary | Change in Modified Ashworth Test | The Modified Ashworth Scale is a 6 point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Stops While Walking Test | The SWWT can be used to determine the effects of attentional demands during walking by introducing a secondary task, talking, while walking. The subject walks at a pre-selected comfortable speed. Yes or no questions are asked while the subject is walking. The test is positive if the subject stops or demonstrates deviations at a result of talking while walking. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Berg Balance Scale | The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in 5 Times Sit to Stand Test | The 5xSST is used to measure functional lower extremity strength during the transitional movement of sit to stand. The individual is timed in moving from the start position of sitting, arms across chest, in a standard chair without armrests to fully standing five times. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Timed Up And Go | The TUG is a timed test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Functional Reach Test | The Functional Reach test is used to objectively measure a person's stability by measuring the distance an individual can reach forward while standing without taking a step. This is performed three times. The results of the last two trials are averaged to determine the result of the exam. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) | |
| Secondary | Change in Modified Functional Reach | The Modified Functional Reach test is used to assess the stability of individuals who cannot stand by measuring the distance they can reach forward while sitting without rotating. This is performed in three different standard positions three times each with a 15 second rest break between each trial. The results of the last two trials in each direction are averaged to determine the result of the exam. | Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit) |