Exoskeleton Training on Balance Control and Turning in Ambulation in Individuals With Incomplete Spinal Cord Injury

NCT06971510 | Active Not Recruiting DMC

• 1 other identifier: HE-OT2021/16
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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 control and turning during ambulation and quality of life in this population. The study mainly involves interventions with participants utilizing exoskeleton devices to explore the influence on mobility, stability, and neuroplasticity, providing new insights into the potential benefits of exoskeleton training for individuals with incomplete spinal cord injuries.

Conditions

Spinal Cord Injuries

Keywords

Exoskeleton training; Balance; Turning; Gait; Neuroplasticity; Quality of life

Outcome Measures

Primary Outcomes (2)

• Duration of a turn

  The participants are asked to walk a straight line of 1 meter, execute a 180-degree turn, and return to the starting position as quickly and safely as possible. Participants have the flexibility to use any necessary walking aids and wear their ankle-foot orthotics as needed. A turn is defined as starting and completing a 180-degree change in walking direction at a marked turn spot on the floor. The start of the turn is determined as the last foot contact prior to the inanition of the direction change. The end of the turn is determined as the last foot contact when both feet turn in the backward direction. Two tripod-mounted video cameras are placed in sagittal plane and frontal plane respectively. An assessor will view the videotapes of the turn by using a video-cassette player. The duration of a turn will be extracted and computed averages of three trials on each side.

  baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up

• Number of steps to a turn

  The participants are asked to walk a straight line of 1 meter, execute a 180-degree turn, and return to the starting position as quickly and safely as possible. Participants have the flexibility to use any necessary walking aids and wear their ankle-foot orthotics as needed. A turn is defined as starting and completing a 180-degree change in walking direction at a marked turn spot on the floor. The start of the turn is determined as the last foot contact prior to the inanition of the direction change. The end of the turn is determined as the last foot contact when both feet turn in the backward direction. Two tripod-mounted video cameras are placed in sagittal plane and frontal plane respectively. An assessor will view the videotapes of the turn by using a video-cassette player. The number of steps to a turn will be extracted and computed averages of three trials on each side.

  baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up

Secondary Outcomes (13)

• Limits of Stability (LOS)

  baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up

• Modified Clinical Test of Sensory Integration and Balance (m-CTSIB)

  baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up

• Muscle strength

  baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up

• Modified Ashworth Scale (MAS)

  baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up

• Modified Functional Reaching Test (MFRT)

  baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up

Other Outcomes (1)

• Brain hemoglobin concentration

  baseline and session 24 (12 Weeks)

Study Arms (3)

Exoskeleton Training Group

EXPERIMENTAL

EksoNR robotic training includes 10 min warm-up, and 5 min cool down (2x/wk, 12 weeks, 24 sessions), minimum 300 steps per session after the third session. The 45 min training excludes set-up/donning/doffing time and includes standing/up time, walking time, and seated rest breaks. The EksoNR training includes weight shift, stepping, straight walking with symmetry gait pattern, and turning with asymmetry gait pattern.

Device: Exoskeleton Training

Conventional Training Group

ACTIVE COMPARATOR

Participants in this group will receive 24-session conventional physical therapy (2x/wk, 12 weeks). Each session lasts 60 minutes, including 10 min warm-up, and 5 min cool-down. Conventional training includes mobilization exercises, strengthening exercises, and balance and gait training. The sessions will be supervised by a trained physiotherapist who will provide guidance and cues to the participants throughout. EksoNR training sessions will be provided after the completion of all the assessments.

Other: Conventional Physical Therapy

Usual Care Group

NO INTERVENTION

Participants in this group continue with daily activities as normal over 12 weeks. No new gait training, mobility therapy, or new medications related to the condition under study, will be commenced during the study period. Participants in this group come to the study sites for evaluations at baseline, 6 weeks, 12 weeks, and one-month follow-up. EksoNR training sessions will be provided after the completion of all the assessments.

Interventions

Exoskeleton Training DEVICE

Using EksoNR to train balance control and walking and turning abilities in patients with incomplete spinal cord injury.

Exoskeleton Training Group

Conventional Physical Therapy OTHER

Using conventional physical therapy methods to train the balance control and walking and turning abilities in patients with incomplete spinal cord injury.

Conventional Training Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead
• The Affiliated BenQ Hospital of Nanjing Medical University: collaborator

Study Sites (3)

Changzhou Sunshine Rehabilitation hospital

Changzhou, Jiangsu, 213022, China

Location

Rehabilitation Medicine Department, The Affiliated BenQ Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210019, China

Location

Hong Kong Metropolitan University

Hong Kong, 999077, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• William WN Tsang, PhD

  Department of Physiotherapy, School of Nursing and Health Studies, Hong Kong Metropolitan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1\) Exoskeleton training group, 2) conventional training group; 3) usual care group

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: May 14, 2025
• Study Start: June 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)