ZEPU-AI3 Lower Limb Feedback Robot Training Study

NCT07705906 | Not Yet Recruiting DMC

• 1 other identifier: PR-1429
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Lower limb motor dysfunction resulting from stroke, spinal cord injury, or other neurological disorders substantially limits mobility, independence, and quality of life. Robotic rehabilitation has emerged as a promising approach to provide intensive, repetitive, task-oriented training. The ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot is designed to deliver interactive lower limb training while providing real-time performance feedback. This pilot randomized controlled trial aims to evaluate the safety, efficacy, and feasibility of ZEPU-AI3-assisted rehabilitation combined with conventional rehabilitation compared with conventional rehabilitation alone in patients with lower limb motor dysfunction. The primary outcomes include safety, feasibility, and changes in lower limb motor function, gait performance, and functional mobility. The findings will provide preliminary evidence to support future large-scale clinical trials and the implementation of robotic rehabilitation in clinical practice.

Conditions

Stroke; Spinal Cord Injuries; Gait Disorders

Keywords

Robotic Rehabilitation; Neurorehabilitation; Feedback Training

Outcome Measures

Primary Outcomes (2)

• Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Incidence of device-related adverse events (AEs) and serious adverse events (SAEs) occurring during the 12-week intervention, including falls, skin breakdown or pressure sores, joint pain or injury, cardiovascular events, fractures, and device malfunction.

  Baseline through Week 12

• Device Tolerability

  Device tolerability assessed by the proportion of planned treatment sessions completed, participant adherence, study withdrawals, and reasons for withdrawal during the 12-week intervention.

  Baseline through Week 12

Secondary Outcomes (7)

• Change in 6-Minute Walk Test Distance

  Baseline and Week 12

• Change in Lower-Limb Muscle Strength on the Medical Research Council (MRC) Muscle Strength Scale

  Baseline and Week 12

• Change in Ambulatory Function on the Functional Ambulation Category (FAC)

  Baseline and Week 12

• Change in Balance on the Berg Balance Scale-Short Form (BBS-SF)

  Baseline and Week 12

• Change in Timed Up and Go (TUG) Test

  Baseline and Week 12

Study Arms (2)

ZEPU-AI3 + Conventional Rehabilitation

EXPERIMENTAL

Participants will receive ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot-assisted rehabilitation in addition to conventional rehabilitation according to the study protocol.

Device: ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot; Other: Conventional Rehabilitation

Conventional Rehabilitation

ACTIVE COMPARATOR

Participants will receive conventional rehabilitation according to institutional standard care without ZEPU-AI3 robotic training.

Other: Conventional Rehabilitation

Interventions

ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot DEVICE

Participants assigned to the experimental arm will receive rehabilitation using the ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in addition to conventional rehabilitation. Robot-assisted training will be delivered according to the approved study protocol, including supervised lower-limb feedback training sessions combined with standard rehabilitation care.

ZEPU-AI3 + Conventional Rehabilitation

Conventional Rehabilitation OTHER

Participants assigned to the control arm will receive conventional rehabilitation according to the standard clinical practice of the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Conventional rehabilitation may include therapeutic exercises, gait training, balance training, strengthening exercises, and other standard rehabilitation interventions as indicated.

Conventional Rehabilitation; ZEPU-AI3 + Conventional Rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 and ≤ 60 years. This age limit is chosen because individuals with this age range generally have better cardiopulmonary reserve and musculoskeletal tolerance, allowing safer participation in intensive robotic-assisted training with reduced risk of adverse events. Excluding younger patients minimizes heterogeneity related to growth, neurodevelopmental factors and congenital disorders, which may influence gait mechanics and response to robotic therapy. Excluding older adults (\>60 years) helps reduce confounding from age-related degenerative changes that may affect gait outcomes and safety.
• Able to provide informed consent and understand instructions which ensures participants can actively engage in therapy, follow safety instructions and report adverse events.
• Weight ≤ 100 kg (as per device spec) and height within device adjustable range (manufacturer spec). Exceeding weight or height limits may compromise mechanical support, safety, and accurate gait training.
• Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, untreated DVT) through pre-screening with necessary investigations.

You may not qualify if:

• Complete spinal cord injury with inability to bear any weight as it requires the patient to actively support some body weight or participate in stepping movements.
• Severe cognitive impairment (e.g., MMSE \< 24) preventing safe participation.
• Severe spasticity (Modified Ashworth Scale \> 3) in lower limbs. High muscle tone or rigidity increases risk of joint strain, skin injury and falls during robotic-assisted training.
• Unstable fractures, severe hip/knee contractures (\> 30° fixed flexion), severe osteoarthritis requiring imminent surgery. They can pose high risk for injury during weight-bearing or gait cycles.
• Uncontrolled cardiac arrhythmia, pacemaker incompatibility or implanted electronic device incompatible with robot sensors. Individuals with these conditions may face elevated risk of adverse cardiac events or device malfunction.
• Pregnancy as safety data for robotic exoskeleton use in pregnant individuals are lacking.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, Dhaka Division, 1000, Bangladesh

Location

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries; Mobility Limitation

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Md. Abdus Shakoor, Ph.D.

  Department of Physical Medicine & Rehabilitation, Bangladesh Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

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, Bangladesh Medical University

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)