Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS
- Conditions
- Musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS
- Registration Number
- JPRN-UMIN000002969
- Lead Sponsor
- niversity of Tsukuba
- Brief Summary
Thirty-eight patients with limited mobility were enrolled. The underlying diseases were stroke (n=12), spinal cord disorders (n=8), joint diseases (n=4), and other diseases (n=14). Thirty-two patients completed 16 sessions of training with the HAL. The results of the 10-m walk test included significant improvements in gait speed, number of steps, and cadence. Although improvements were observed in balance ability, as measured with the Timed Up & Go test and Berg Balance Scale, the results were not statistically significant. No serious adverse events were observed during the training.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
The following patients will be excluded: 1. Patients with inadequately treated cardiovascular disorders. 2. Patients with inadequately treated respiratory disorders. 3. Patients with intellectual impairments that interfere with their understanding of the explanetion of the experiment or instructions they need to follow. 4. Patients with moderate to severe articular problem, including contracture in the lower extremities. 5. Patients with a moderate to severe degree of involuntary movements, ataxia, or impairment of postural reflex in the trunk or lower extremities. 6. Patients with severe spasticity in the lower extremities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Balancing and walking ability will be evaluated with the Functional Balance Scale, the 10-m walking test, and the 3-m timed up and go test.
- Secondary Outcome Measures
Name Time Method 1. Vital signs (heart rate and blood pressure) 2. Severity of the disorder 3. Activities of daily living (Barthel Index) 4. Health-related quality of life (SF-36) 5. Profile of mood states (POMS) 6. Range of motion of the joints in the lower extremities 7. Muscle strength of the major muscles in the lower extremities 8. Rate of perceived exertion (Borg Scale) 9. Muscle action potentials 10. Satisfaction with the assistance in mobility provided by HAL 11. Amount of time needed to put on and take off the apparatus 12. Sabilometry 13. Functional MRI images of the brain 14. Three-dimensional motion analysis 15. Adverse events