Status:
ACTIVE_NOT_RECRUITING
Exoskeleton Training on Balance Control and Turning in Ambulation in Individuals With Incomplete Spinal Cord Injury
Lead Sponsor:
Hong Kong Metropolitan University
Collaborating Sponsors:
The Affiliated BenQ Hospital of Nanjing Medical University
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study investigates the impact of exoskeleton training on individuals with incomplete spinal cord injury (iSCI). Investigators focus on assessing how the use of the exoskeleton influences balance ...
Detailed Description
Spinal cord injury (SCI) poses profound challenges to individuals, disrupting complex neural pathways responsible for motor and sensory functions. Across a spectrum of impairments, the ability to navi...
Eligibility Criteria
Inclusion
- Aged 18-65 years
- Traumatic or non-traumatic SCI, \> 6 months since SCI onset Motor incomplete SCI (American Spinal Injury Association Impairment Scale, AIS C and D), neurologic level of injury (NLI) between C1-L2 (inclusive), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
- Able to walk with or without walking aid independently for at least 2 meters
- No current or history of other neurological conditions
- Community-dwelling or living in a rehabilitation facility
- Medically stable for full weight-bearing locomotor training including 15-minute standing frame trial to assess standing tolerance
- Weigh 220 pounds (100 kg) or less (exoskeleton equipment requirement)
- Between approximately 1.5 m and 1.9 m (5'0" and 6'4") tall (exoskeleton equipment requirement)
- Standing hip width of approximately 45 cm (18") or less (exoskeleton equipment requirement)
- Sufficient range of motion (ROM) to achieve a normal, reciprocal gait pattern, and normal sit-to-stand transitions.
- Hip extension greater than or equal to 5-degree Knee extension greater than or equal to 5-degree Ankle dorsiflexion greater than or equal to 0-degree
- Sufficient upper extremity strength to use a front wheeled walker by manual muscle testing (minimum triceps strength bilaterally of 3/5 of Oxford Scale, shoulder abduction and flexion/extension 4/5 of Oxford Scale)
Exclusion
- AIS-A SCI or AIS-B SCI
- Have been trained in exoskeleton or other robotic device for locomotor training within the past 4 months except for one or two training/demonstration sessions
- Currently involved in another intervention study
- Any medical issue that precludes full weight-bearing locomotor training including but not limited to:
- Spinal instability (or spinal orthotic unless cleared by physician) Acute deep vein thrombosis (DVT) with activity restrictions Severe, recurrent autonomic dysreflexia (AD) requiring medical intervention Heterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees Two or more pathological fractures in the last 48 months in a major weight-bearing bone (femur or tibia) in the lower extremity Hip subluxation (x-rays will be obtained for individuals injured prior to 10 years of age)
- Any medical issue that would affect participant safety either due to cognitive deficits/impulsivity, intolerance to mild exercise, or other factors
- Any issue that would confound results such as a concurrent neurological injury or disorder (other than SCI) or other factors
- Skin integrity issues in areas that contact the device (including abdominal ostomies) or that would prohibit sitting
- Pregnancy
- Participants who do not meet the exoskeleton equipment requirements
- Modified Ashworth Scale (MAS) = 4 in the majority of lower extremity joints (e.g. greater than or equal to four joint movements in bilateral lower extremities when testing hip flexion/extension, knee flexion/extension, ankle dorsi/plantar flexion)
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06971510
Start Date
June 1 2024
End Date
November 30 2025
Last Update
May 14 2025
Active Locations (3)
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1
Changzhou Sunshine Rehabilitation hospital
Changzhou, Jiangsu, China, 213022
2
Rehabilitation Medicine Department, The Affiliated BenQ Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210019
3
Hong Kong Metropolitan University
Hong Kong, China, 999077