Clinical trial NCT06971510: Exoskeleton Training on Balance Control and Turning in Ambulation in Individuals With Incomplete Spinal Cord Injury
Official title: The Effectiveness of Robotic Exoskeleton on Sensori-motor Performance in Subjects With Incomplete Spinal Cord Injury: A Functional Near-Infrared Spectroscopy Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Exoskeleton training
Balance
Turning
Gait
Neuroplasticity
Quality of life
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
Collaborators: name: The Affiliated BenQ Hospital of Nanjing Medical University
First posted: 2025-05-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1) Exoskeleton training group, 2) conventional training group; 3) usual care group
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Duration of a turn
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Number of steps to a turn
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
Secondary outcomes:
measure: Limits of Stability (LOS)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Modified Clinical Test of Sensory Integration and Balance (m-CTSIB)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Muscle strength
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Modified Ashworth Scale (MAS)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Modified Functional Reaching Test (MFRT)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Berg Balance Scale (BBS)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: The Timed Up and Go Test (TUGT)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: 10 Meter Walk Test (10MWT)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Walking index for spinal cord injury (WISCI II)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Fall incidence
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: The 36-Item Short Form Health Survey (SF-36)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Falls Efficacy Scale International (FES-I)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
measure: Physical Activity Scale for Persons with Physical Disabilities (PASIPD)
timeFrame: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
Other outcomes:
measure: Brain hemoglobin concentration
timeFrame: baseline and session 24 (12 Weeks)
Locations:
city: Changzhou
country: China
facility: Changzhou Sunshine Rehabilitation hospital
state: Jiang Su
city: Nanjing
country: China
facility: Rehabilitation Medicine Department, The Affiliated BenQ Hospital of Nanjing Medical University
state: Jiangsu
city: Hong Kong
country: China
facility: Hong Kong Metropolitan University
Study officials:
affiliation: Department of Physiotherapy, School of Nursing and Health Studies, Hong Kong Metropolitan University
name: William WN Tsang, PhD
role: STUDY_CHAIR
References: