ZEPU-2000 Limb Rehabilitation Trainer Study (ZEPU2000RCT)

NCT07749612 | Not Yet Recruiting DMC

• 1 other identifier: PR-1435
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether the ZEPU-2000A, ZEPU-2000D and ZEPU-2000E robotic rehabilitation trainers help people with weakness or movement problems in their arms and legs. These devices are used to guide repeated arm and leg movements as part of rehabilitation therapy. The study will also look at whether the devices are safe to use. The main questions it aims to answer are: Is training with the ZEPU-2000 devices safe, and how well do patients tolerate and stick with the training sessions? Does adding robotic training to usual rehabilitation improve muscle strength, joint movement, balance, walking, and daily function more than usual rehabilitation alone? Researchers will compare a group receiving robotic-assisted rehabilitation plus usual care to a group receiving usual rehabilitation care alone, to see whether the robotic devices provide added benefit. Participants will: Be adults aged 18-60 with arm and/or leg movement problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or an orthopedic condition Attend training sessions 3 times a week for 12 weeks (about 36 sessions total), each lasting approximately 45 minutes Undergo assessments of strength, movement, balance, and daily function at the start of the study and every 2 weeks throughout the 12-week period Be monitored for any side effects or safety concerns, such as skin irritation, falls, or discomfort, at every session

Conditions

Stroke; Traumatic Brain Injury; Upper Extremity Motor Dysfunction; Incomplete Spinal Cord Injury (SCI); Lower Extremity Motor Dysfunction

Keywords

Robotic rehabilitation; ZEPU-2000A; ZEPU-2000D; ZEPU-2000E; Active and passive rehabilitation; 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 or injury, cardiovascular events, fracture, and device malfunction.

  Baseline (T=0) up to 12 weeks, assessed every 2 weeks

• Device Tolerability

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

  Baseline (T=0) up to 12 weeks, assessed every 2 weeks

Secondary Outcomes (7)

• Change in Muscle Strength

  Baseline (T=0) to 12 weeks, assessed every 2 weeks

• Change in Muscle Spasticity

  Baseline (T=0) to 12 weeks, assessed every 2 weeks

• Change in Functional Ambulation

  Baseline (T=0) to 12 weeks, assessed every 2 weeks

• Change in Functional Independence

  Baseline (T=0) to 12 weeks, assessed every 2 weeks

• Change in Functional Mobility

  Baseline (T=0) to 12 weeks, assessed every 2 weeks

Study Arms (2)

Robotic-Augmented Rehabilitation Group

EXPERIMENTAL

Participants receive standard-of-care rehabilitation combined with robotic-assisted therapy using the ZEPU-2000A, ZEPU-2000D, or ZEPU-2000E upper and lower limb trainer systems. Robotic training is provided 3 times weekly for 12 weeks (approximately 36 sessions), each session lasting approximately 45 minutes and including warm-up, device set-up, structured passive/active-assisted/active training, and cool-down.

Device: ZEPU-2000A; Device: ZEPU-2000D; Device: ZEPU-2000E; Behavioral: Standard Rehabilitation Care

Usual Care Group

ACTIVE COMPARATOR

Participants receive standard-of-care rehabilitation alone, including individualized rehabilitation and exercise (e.g., strengthening, balance training, stretching, gait retraining), without robotic-assisted therapy.

Behavioral: Standard Rehabilitation Care

Interventions

ZEPU-2000A DEVICE

An electromechanical upper limb rehabilitation system providing passive, active-assisted, and active-resisted movement training across the shoulder, elbow, and wrist. Integrated sensors record range of motion, movement speed, and torque, with software-guided protocols and real-time feedback. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.

Robotic-Augmented Rehabilitation Group

ZEPU-2000D DEVICE

A lower limb robotic trainer with actuated joints at the hip, knee, and ankle supporting repetitive stepping and weight-bearing training that simulates gait kinematics. Provides passive to active-assisted progression with force sensors and visual biofeedback on step length, cadence, and symmetry. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.

Robotic-Augmented Rehabilitation Group

ZEPU-2000E DEVICE

A multifunctional robotic system combining upper and lower limb training on a single platform, supporting task-oriented movements such as reaching-to-grasp, stepping, and sit-to-stand. Intelligent control adjusts support level in real time based on performance. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.

Robotic-Augmented Rehabilitation Group

Standard Rehabilitation Care BEHAVIORAL

Individualized conventional rehabilitation without robotic assistance, including therapist-led strengthening exercises, balance training, stretching, and gait retraining, delivered per institutional protocol throughout the 12-week study period.

Robotic-Augmented Rehabilitation Group; Usual Care Group

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: stroke with onset between 2 and 24 months prior to enrolment; incomplete spinal cord injury (neurological level C5 and below), classified as ASIA Impairment Scale C or D; traumatic brain injury with persistent upper-limb functional limitation; or orthopedic/post-surgical conditions involving the shoulder, elbow, wrist, or hand with persistent functional impairment for more than 3 months
• 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-2000A, ZEPU-2000D, and ZEPU-2000E systems, 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 less than 24, that would compromise safe participation Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score greater than 3
• Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., greater than 30 degrees), or severe pain limiting safe robotic training
• Uncontrolled cardiac arrhythmia, or presence of a pacemaker or other implanted electronic medical device 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; Brain Injuries, Traumatic; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior

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 27, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)