Rehabilitation of neurologically impaired and spinal cord injured: exoskeleton trial

Not Applicable

Completed

• Conditions: Rehabilitation of individuals with neurological impairments; Nervous System Diseases

• Registration Number: ISRCTN11222157
• Lead Sponsor: Atlantic Technological University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-20
• Study Completion: 2022-11-11
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Adults with a neurological impairment (e.g., spinal cord injury, multiple sclerosis, acquired brain injury, stroke)
2. Aged 18-70 years old
3. Height: =157.5 and =188 cm and body mass: =100 kg
4. Able to signal pain, discomfort, or fear reliably
5. Functional joint mobility (ankle dorsiflexion = neutral; knee flexion = 0–120°; hip flexion = 0–90°; and hip extension = 0–10°)
6. No orthopaedic surgery or neurosurgery within 6 months prior
7. A stable cardiovascular system

Exclusion Criteria

1. Contractures, fractures or joint dislocations in the lower extremities
2. Osteoporosis
3. Height: <157.5 and >188 cm and body mass >100 kg
4. Unequal leg length
5. Unhealed skin lesions in the lower limbs
6. Thromboembolic diseases or cardiovascular instability

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The physiological response to the intervention, measured using:<br> 1. A range of cardiorespiratory measurements generated by the Ganshorn PowerCube®<br> 2. HR recorded using a Polar FT2 (GEN 90037558, Electro, Finland) chest strap HR monitor<br> 3. RPE measured using the Borg Scale (6-20 scale)<br> These measurements will be recorded throughout the 6MWT, which will be conducted at baseline, mid, and post-intervention.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Gait function is measured using the 6MWT which includes total walking distance and walking speed and will be recorded at baseline, mid, and post intervention<br> 2. Functional mobility will be measured by a qualified and registered chartered physiotherapist using specific exoskeleton protocols at baseline, mid, and post intervention<br> 3. Biomechanical response will be measured using Shimmer 3 EMG sensors, which will record lower limb muscle activation, acceleration and angular velocity throughout the 6MWT at baseline, mid, and post intervention<br> 4. Emotional response will be measured using a Shimmer 3 GSR+ unit during the 6MWT at baseline, mid, and post intervention<br> 5. Quality of life will be measured using the EQ-5D-5L quality of life questionnaire developed by EuroQol at baseline, mid, and post intervention<br>