ZEPU-AI Series Limb Feedback Robot Training Study (ZEPUAISRCT)

NCT07749625 | Not Yet Recruiting DMC

• 1 other identifier: PR-1436
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether robotic rehabilitation devices (ZEPU-AI2, AI4, AI6 Plus, and AI7A) are feasible, safe, and effective for adults with upper or lower limb motor problems. These problems can result from stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic surgery. The main questions it aims to answer are: Is robotic rehabilitation training safe and practical to deliver alongside conventional therapy? Does adding robotic-assisted therapy improve motor function, balance, gait, and independence in daily activities compared to conventional rehabilitation alone? What side effects or device-related problems, if any, occur during robotic training? The Investigators will compare a robotic-augmented rehabilitation group to a control group receiving conventional rehabilitation alone, to see if adding robotic therapy leads to better recovery. Participants will: Receive robotic-assisted therapy sessions three times a week for 12 weeks, each lasting about 45 minutes (robotic group), or continue with conventional rehabilitation alone (control group) Undergo assessments of movement, balance, walking ability, and daily function before and after the study period Be monitored for any side effects or complications related to the device or training

Conditions

Stroke; Spinal Cord Injuries; Brain Injuries, Traumatic; Movement Disorder, Lower Extremity; Movement Disorder, Upper Extremity

Keywords

Robotic Rehabilitation; ZEPU-AI2; ZEPU-AI4; ZEPU-AI6 Plus; ZEPU-AI7A; Neurorehabilitation; Musculoskeletal Rehabilitation

Outcome Measures

Primary Outcomes (2)

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

  Number of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, fracture, and device malfunction.

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

• Device Tolerability

  Number of training sessions completed relative to sessions planned, and number of participant drop-outs with reasons for discontinuation.

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

Secondary Outcomes (9)

• Change in Walking Distance on 6-Minute Walk Test

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

• Change in Muscle Strength on MRC Scale

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

• Change in Functional Ambulation Category (FAC) Score

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

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

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

• Change in Spasticity on Modified Ashworth Scale (MAS)

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

Study Arms (2)

Robotic-Augmented Rehabilitation (Intervention)

EXPERIMENTAL

Participants (n=18 per device cohort) receive standard-of-care physiotherapy plus robotic-assisted rehabilitation using the ZEPU-AI2, AI4, AI6 Plus, or AI7A system, 3 sessions/week (\~45 min each) for 12 weeks (36 sessions total), including warm-up, device donning, structured training (upper/lower limb, gait, or isokinetic depending on device), and cool-down, delivered under supervision of trained physiotherapists.

Device: ZEPU-AI2; Device: ZEPU-AI4; Device: ZEPU-AI6 Plus; Device: ZEPU-AI7A; Behavioral: Standard-of-Care Physiotherapy

Usual Care (Control)

ACTIVE COMPARATOR

Participants (n=18 per device cohort) receive standard-of-care rehabilitation alone (balance training, lower-limb strengthening, stretching, and gait retraining as per institutional protocol) without the addition of robotic-assisted therapy.

Behavioral: Standard-of-Care Physiotherapy

Interventions

ZEPU-AI2 DEVICE

Upper Extremity Feedback Training and Evaluation System Intervention Description: Robotic upper-extremity feedback training and evaluation device enabling active, passive, and active-assisted movement training with real-time feedback for patients with upper-limb motor dysfunction, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.

Robotic-Augmented Rehabilitation (Intervention)

ZEPU-AI4 DEVICE

Multi-Joint Isokinetic Training and Evaluation System Intervention Description: Robotic multi-joint isokinetic training and evaluation device supporting controlled, resistance-based rehabilitation and objective strength assessment of upper- and lower-limb joints, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.

Robotic-Augmented Rehabilitation (Intervention)

ZEPU-AI6 Plus DEVICE

Multi-axis robotic arm device that simulates physiological upper-limb movement patterns for three-dimensional active and passive training, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.

Robotic-Augmented Rehabilitation (Intervention)

ZEPU-AI7A DEVICE

Motor-driven robotic device providing active and passive rehabilitation of the upper and lower limbs, separately or simultaneously, via circular motion training, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.

Robotic-Augmented Rehabilitation (Intervention)

Standard-of-Care Physiotherapy BEHAVIORAL

Conventional physiotherapy comprising balance training, lower-limb strengthening, stretching, and gait retraining delivered per institutional protocol; provided alone in the control arm and alongside robotic training in the intervention arm.

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

Eligibility Criteria

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

You may qualify if:

• Presence of upper-limb motor dysfunction, with or without concurrent lower-limb impairment, due to one of the following conditions: (a) Stroke, with onset between 2 and 24 months prior to enrollment; (b) Incomplete spinal cord injury (ASIA Scale B, C, or D); (c) Traumatic brain injury; or (d) Orthopedic disorders affecting upper and/or lower limb motor function
• Age between 18 and 60 years
• Ability to understand study procedures and follow instructions, and to provide written informed consent (or assent with guardian consent where applicable)
• Body weight and limb anthropometry compatible with ZEPU-AI2, AI4, AI6 Plus, and AI7A systems, as per manufacturer specifications
• Medically stable and cleared by a physician for robotic rehabilitation, with no active infection, uncontrolled cardiac or respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated deep vein thrombosis

You may not qualify if:

• Complete spinal cord injury or profound motor paralysis preventing safe interaction with robotic devices
• Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \< 24, that would compromise safe participation
• Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score \> 3
• Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., \> 30°), or severe pain limiting safe robotic training
• Uncontrolled cardiac arrhythmia, presence of a pacemaker, or other implanted electronic medical devices incompatible with robotic 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; Brain Injuries, Traumatic; Movement Disorders

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; Brain Injuries; Craniocerebral Trauma

Study Officials

• Md. Abdus Shakoor, Ph.D.

  Bangladesh Medical University

  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 and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)