Paraplegia
Conditions
Keywords
exoskeleton walking system, paraplegia, paralysis
Brief summary
It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to many secondary medical problems such as diabetes and insulin resistance, obesity, constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of life, and more. The ReWalk-I exoskeleton walking device permits investigation of the potential benefits of frequent upright posture and walking on many of the secondary consequences of spinal cord injury. The researchers are investigating the ability of persons with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright and walking on several of these secondary medical consequences of spinal cord injury.
Detailed description
Potential participants will be pre-screened with the inclusion criteria for eligibility. The informed consent process will begin for those participants who have been determined to meet the inclusion criteria. After the potential participant's signed consent has been provided, further evaluations for eligibility will be performed (e.g., there are several medical and physical exclusion criteria). Those potential participants who meet both the inclusion and exclusion criteria will be eligible to enroll into the ReWalk-I study. Baseline evaluations and personalized measurements for fitting to the ReWalk-I will be performed over one week, before the training sessions begin. The ReWalk sessions will consist of a Learning Phase (12 sessions in 4 weeks) and a Training Phase (18 sessions in 6 weeks). These times may vary by each participant's ReWalk learning curve. Training will begin with sit-to-stand, stand-to-sit, and standing balance activities. Progression to walking will occur as skills advance. Each session will be an average 50 minutes, with 3 sessions per week. The skills to be learned include 1) sit-to-stand, 2) stand-to-sit, 3) 2-arm standing balance, 4) 1-arm standing balance, 5) walking, and 6) stair climbing. The study evaluations will be repeated after the Learning Phase, after the Training Phase and 1-month post training follow-up.
Interventions
DEVICEpowered exoskeleton
Sponsors
James J. Peters Veterans Affairs Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females with paraplegia 2. Duration of SCI \>6 months 3. Ages 18 to 65 y 4. Height 160 to 190cm (63-75in or 5'3 to 6'3) 5. Weight \<100kg (\<220 lb) 6. Ability to give informed consent
Exclusion criteria
1. Diagnosis of neurological injury other than SCI including: * Multiple sclerosis (MS) * Stroke * Cerebral Palsy (CP) * Amyotrophic lateral sclerosis (ALS) * Traumatic Brain injury (TBI) * Spina bifida * Parkinson's disease (PD) * Other neurological condition that the study physician considers in his/her clinical judgment to be exclusionary 2. Severe concurrent medical disease, illness or condition 3. Recent lower extremity fracture within the past 2 years; 4. DXA results indicating a t-score below -3.0 and knee BMD \<0.70 gm/cm2 5. Systemic or peripheral infection 6. Atherosclerosis, congestive heart failure, or history of myocardial infarction 7. Trunk and/or lower extremity pressure ulcers; 8. Other illness, that the study physician considers in his/her clinical judgment to be exclusionary 9. Severe spasticity (defined by an Ashworth score of \>4.0 or clinical impression of the study physician or physical therapist) 10. Significant contractures defined as flexion contracture limited to 35º at the hip and 20º at the knee; 11. Diagnosis of heterotrophic ossification of the lower extremities; 12. Femoral neck or the total proximal femur bone mineral density T-scores \< -3.0 13. Psychopathology documentation in the medical record or history of that may conflict with study objectives 14. Hypertension (SBP\>140, DBP\>90) 15. Pregnancy and/or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count to Achieve Mobility Skills | ReWalk training at 4 and 12 weeks, and 1-month follow-up | 1\. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance: 1. Sit-to-stand, 2. Stand-to-sit, 3. Standing balance for 1 minutes with both crutches, 4. Standing balance for 30 seconds with one crutch, 5. Ten meter walk in ≤2 minutes, 6. Walk ≥30 meters in 6-minutes, and 7. Ascend, turn around and descend 4 stairs in 5 minutes. |
Countries
United States
Participant flow
Recruitment details
All participants were recruited, consented, screened and eligible subjects were enrolled at the James J Peters VAMC
Participants by arm
| Arm | Count |
|---|---|
| Exoskeleton Trained to use powered exoskeleton for overground ambulation | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Exoskeleton |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 7 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Count to Achieve Mobility Skills
1\. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance: 1. Sit-to-stand, 2. Stand-to-sit, 3. Standing balance for 1 minutes with both crutches, 4. Standing balance for 30 seconds with one crutch, 5. Ten meter walk in ≤2 minutes, 6. Walk ≥30 meters in 6-minutes, and 7. Ascend, turn around and descend 4 stairs in 5 minutes.
Time frame: ReWalk training at 4 and 12 weeks, and 1-month follow-up
Population: number of participants that were able to achieve the mile stone described in outcome measure description
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Exoskeleton | Count to Achieve Mobility Skills | No assistance sit-to-stand (4 weeks) | Passed | 9 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance sit-to-stand (4 weeks) | Not Passed | 3 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance stand-to-sit (4 week) | Not Tested | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance 10 walk in ≤2 min (1 mo FU) | Passed | 6 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance walk ≥30 meters in 6-min (4 weeks) | Not Tested | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance ascend and descend stairs (1 mo FU) | Not Passed | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance sit-to-stand (4 weeks) | Not Tested | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance sit-to-stand (12 weeks) | Passed | 10 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance sit-to-stand (12 weeks) | Not Passed | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance sit-to-stand (12 weeks) | Not Tested | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance sit-to-stand (1 month follow-up) | Passed | 9 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance sit-to-stand (1 month follow-up) | Not Passed | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance sit-to-stand (1 month follow-up) | Not Tested | 2 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance stand-to-sit (4 week) | Passed | 9 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance stand-to-sit (4 week) | Not Passed | 3 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance stand-to-sit (12 week) | Passed | 10 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance stand-to-sit (12 week) | Not Passed | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance stand-to-sit (12 week) | Not Tested | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance stand-to-sit (1 month follow-up) | Passed | 9 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance stand-to-sit (1 month follow-up) | Not Passed | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance stand-to-sit (1 month follow-up) | Not Tested | 2 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 2 crutches 1 min (4 weeks) | Passed | 11 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 2 crutches 1 min (4 weeks) | Not Passed | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 2 crutches 1 min (4 weeks) | Not Tested | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 2 crutches 1 min (12 weeks) | Passed | 11 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 2 crutches 1 min (12 weeks) | Not Passed | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 2 crutches 1 min (12 weeks) | Not Tested | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 2 crutches 1 min (1 mo FU) | Passed | 11 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 2 crutches 1 min (1 mo FU) | Not Passed | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 2 crutches 1 min (1 mo FU) | Not Tested | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 1 crutch 30 sec (4 weeks) | Passed | 10 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 1 crutch 30 sec (4 weeks) | Not Passed | 2 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 1 crutch 30 sec (4 weeks) | Not Tested | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 1 crutch 30 sec (12 weeks) | Passed | 11 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 1 crutch 30 sec (12 weeks) | Not Passed | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 1 crutch 30 sec (12 weeks) | Not Tested | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 1 crutch 30 sec (1 mo FU) | Passed | 10 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 1 crutch 30 sec (1 mo FU) | Not Passed | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assist standing 1 crutch 30 sec (1 mo FU) | Not Tested | 2 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance 10 walk in ≤2 min (4 weeks) | Passed | 4 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance 10 walk in ≤2 min (4 weeks) | Not Passed | 8 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance 10 walk in ≤2 min (4 weeks) | Not Tested | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance 10 walk in ≤2 min (12 weeks) | Passed | 7 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance 10 walk in ≤2 min (12 weeks) | Not Passed | 4 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance 10 walk in ≤2 min (12 weeks) | Not Tested | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance 10 walk in ≤2 min (1 mo FU) | Not Passed | 4 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance 10 walk in ≤2 min (1 mo FU) | Not Tested | 2 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance walk ≥30 meters in 6-min (4 weeks) | Passed | 4 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance walk ≥30 meters in 6-min (4 weeks) | Not Passed | 8 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance walk ≥30 meters in 6-min (12 weeks) | Passed | 7 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance walk ≥30 meters in 6-min (12 weeks) | Not Passed | 4 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance walk ≥30 meters in 6-min (12 weeks) | Not Tested | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance walk ≥30 meters in 6-min (1 mo FU) | Passed | 6 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance walk ≥30 meters in 6-min (1 mo FU) | Not Passed | 4 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance walk ≥30 meters in 6-min (1 mo FU) | Not Tested | 2 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance ascend and descend stairs (4 weeks) | Passed | 1 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance ascend and descend stairs (4 weeks) | Not Passed | 3 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance ascend and descend stairs (4 weeks) | Not Tested | 8 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance ascend and descend stairs (12 weeks) | Passed | 4 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance ascend and descend stairs (12 weeks) | Not Passed | 0 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance ascend and descend stairs (12 weeks) | Not Tested | 8 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance ascend and descend stairs (1 mo FU) | Passed | 4 Participants |
| Exoskeleton | Count to Achieve Mobility Skills | No assistance ascend and descend stairs (1 mo FU) | Not Tested | 8 Participants |