ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)

NCT07735676 | Not Yet Recruiting DMC

• 1 other identifier: PR-1427
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and walking ability in other countries. However, this type of technology has not yet been carefully studied in Bangladesh. This study will test a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who have difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals are to find out whether using this robotic device alongside standard physical therapy is feasible (practical to carry out) and safe, and to explore whether it helps improve walking speed, balance, muscle strength, and daily function compared with standard physical therapy alone. Thirty-two participants will take part. Half will receive robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while the other half will receive usual rehabilitation therapy alone. Participants will be assessed regularly using standard walking, balance, and strength tests over the 12-week period. The results of this study will help doctors and researchers understand whether this robotic technology can be safely and effectively introduced into rehabilitation care in Bangladesh.

Conditions

Stroke; Spinal Cord Injuries (SCI); Gait Disorders, Neurologic

Keywords

Gait Training; Robotic Rehabilitation; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Incidence of Device-Related Adverse Events and Serious Adverse Events

  Number and proportion of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, and fracture, during the intervention and follow-up period.

  Baseline (T=0) through 12-week intervention period and follow-up, assessed every 2 weeks

Secondary Outcomes (7)

• Change in Six-Minute Walk Distance (6MWD)

  Baseline (T=0), every 2 weeks through 12 weeks

• Change in Medical Research Council (MRC) Muscle Strength Scale

  Baseline (T=0), every 2 weeks through 12 weeks

• Change in Functional Ambulation Category (FAC) Score

  Baseline (T=0), every 2 weeks through 12 weeks

• Change in Berg Balance Scale Score

  Baseline (T=0), every 2 weeks through 12 weeks

• Change in Timed Up and Go (TUG) Test

  Baseline (T=0), every 2 weeks through 12 weeks

Study Arms (2)

Robotic-Augmented Rehabilitation Group

EXPERIMENTAL

Participants (n=16) will receive robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System in addition to standard-of-care rehabilitation. Training will be delivered 3 times per week for 12 weeks (36 sessions total), each session approximately 45 minutes, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration will be progressively adjusted based on participant tolerance and performance. Sessions will be supervised by trained physiatrists and physiotherapists at the Robotic Rehabilitation Centre, BMU. Standard-of-care rehabilitation (individualized rehabilitation and exercise) will continue in parallel.

Device: ZEPU-AI1 Gait Training and Evaluation System; Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)

Usual Care (Control) Group

ACTIVE COMPARATOR

Participants (n=16) will receive standard-of-care rehabilitation alone, without robotic-assisted gait training. This includes individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU, matched in overall therapeutic content to the conventional-therapy component received by the intervention group.

Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)

Interventions

Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise) BEHAVIORAL

Participants will receive individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU. This standard-of-care rehabilitation program is tailored to each participant's functional status and needs, and is matched in overall therapeutic content and intensity across both study groups. It is delivered without any robotic-assisted device and represents the conventional-therapy component of care for individuals undergoing gait and mobility rehabilitation.

Robotic-Augmented Rehabilitation Group; Usual Care (Control) Group

ZEPU-AI1 Gait Training and Evaluation System DEVICE

Participants will receive robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System, a robotic device providing body-weight-supported, guided gait training. Training will be delivered 3 times per week for 12 weeks (36 sessions total), approximately 45 minutes per session, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration will be progressively adjusted based on participant tolerance and performance

Robotic-Augmented Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Lower-limb motor dysfunction from one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal-cord injury (neurological level T12 and below, ASIA C or D), (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment \>3 months post-surgery
• Age \>18 and ≤60 years
• Able to provide informed consent and understand instructions
• Weight ≤100 kg and height within device adjustable range (per manufacturer specification)
• Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated DVT)

You may not qualify if:

• Complete spinal cord injury with inability to bear any weight
• Severe cognitive impairment (e.g., MMSE \<24) preventing safe participation
• Severe spasticity (Modified Ashworth Scale \>3) in lower limbs
• Unstable fractures, severe hip/knee contractures (\>30° fixed flexion), or severe osteoarthritis requiring imminent surgery
• Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors
• Pregnancy

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries; Gait Disorders, Neurologic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Md. Abdus Shakoor, Ph.D.

CONTACT

+8801819410080; shakoorma@bmu.ac.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)