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

NCT ID: NCT06971510

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-11-30

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.

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 navigate and maneuver during walking, particularly turning, is a significant obstacle for patients with incomplete SCI (iSCI). Despite advances in rehabilitation strategies, turning-while-walking remains a biomechanically demanding task that is often overlooked in traditional interventions that focus primarily on linear gait training.

Turning-while-walking requires coordinated movements of the head, trunk, pelvis, and limbs. Disruption of sensory pathways and impairment of motor control after iSCI complicates this complex process, resulting in impaired balance, increased risk of falls, and decreased quality of life. While traditional rehabilitation methods strive to address these challenges, they often fail to target the specific complexities of turning dynamics.

Robotic exoskeletons are wearable devices designed to enhance mobility for iSCI patients. These innovative technologies are expected to enhance sensorimotor performance by providing external support, promoting gait symmetry, and promoting neuroplasticity through intensive training. Exoskeleton-assisted therapy has the potential not only to restore physical function, but also to promote psychosocial well-being, allowing individuals to participate more fully in daily activities and social interactions.

However, despite the growing body of research demonstrating the benefits of exoskeleton training, its efficacy in improving turning-while-walking performance among individuals with iSCI remains uncertain. Furthermore, the neurological mechanisms underlying the response to exoskeleton training in this population warrant deeper investigation.

This study aims to elucidate the effectiveness of a robotic exoskeleton on sensorimotor performance in subjects with iSCI. By filling gaps in the existing literature through rigorous methodology and comprehensive evaluation, investigators strive to provide valuable insights into the potential of exoskeleton-assisted therapy to optimize rehabilitation outcomes and improve the lives of iSCI survivors. Through a multidimensional approach encompassing both physical and psychosocial domains, this research seeks to pave the way for more tailored and effective interventions in SCI rehabilitation, ultimately fostering greater independence and well-being for those affected by this debilitating condition.

The objective of the cluster randomized controlled trial is to investigate the effectiveness of exoskeleton training specifically on turning-while-walking performance, balance control, gait function, muscle strength, spasticity, quality of life, self-efficacy, and fall incidence in people with iSCI. Moreover, the study will also explore how exoskeleton training may promote neuroplasticity and its relationship with ambulatory function and balance control changes in people with iSCI. The three centers will serve as distinct clusters and will be randomized into three groups: 1) Exoskeleton Training Group (ETG), 2) Conventional Exercise Group (CEG), and 3) Usual Care Control Group (UCG). The ETG and CTG will undergo 24 training sessions over 12 weeks respectively, and the UCG will receive standard care.

Assessments will be conducted at baseline, midpoint (Week 6), post-intervention (Week 12), and one-month post-intervention to evaluate outcomes such as turning-while-walking performance, balance control, gait performance, muscle strength, spasticity, self-efficacy, fall incidence, and quality of life. Additionally, cortical activity will be measured to explore changes in neural pathways and their correlation with turning performance and balance control during ambulation.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exoskeleton Training Group

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.

Group Type: EXPERIMENTAL

Exoskeleton Training

Intervention Type: DEVICE

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

Conventional Training Group

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.

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type: OTHER

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

Usual Care Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exoskeleton Training

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

Intervention Type: DEVICE

Conventional Physical Therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Aged 18-65 years

2. 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)

3. Able to walk with or without walking aid independently for at least 2 meters

4. No current or history of other neurological conditions

5. Community-dwelling or living in a rehabilitation facility

6. Medically stable for full weight-bearing locomotor training including 15-minute standing frame trial to assess standing tolerance

7. Weigh 220 pounds (100 kg) or less (exoskeleton equipment requirement)

8. Between approximately 1.5 m and 1.9 m (5'0" and 6'4") tall (exoskeleton equipment requirement)

9. Standing hip width of approximately 45 cm (18") or less (exoskeleton equipment requirement)

10. 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

11. 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 Criteria

1. AIS-A SCI or AIS-B SCI

2. 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

3. Currently involved in another intervention study

4. 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)

5. Any medical issue that would affect participant safety either due to cognitive deficits/impulsivity, intolerance to mild exercise, or other factors

6. Any issue that would confound results such as a concurrent neurological injury or disorder (other than SCI) or other factors

7. Skin integrity issues in areas that contact the device (including abdominal ostomies) or that would prohibit sitting

8. Pregnancy

9. Participants who do not meet the exoskeleton equipment requirements

10. 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated BenQ Hospital of Nanjing Medical University

UNKNOWN

Sponsor Role: collaborator

Hong Kong Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William WN Tsang, PhD

Role: STUDY_CHAIR

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

Locations

Changzhou Sunshine Rehabilitation hospital

Changzhou, Jiangsu, China

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

Nanjing, Jiangsu, China

Hong Kong Metropolitan University

Hong Kong, , China

Countries

China

Other Identifiers

HE-OT2021/16

Identifier Type: -

Identifier Source: org_study_id