ZEPU-2000 Limb Rehabilitation Trainer Study (ZEPU2000RCT) | NCT07749612

NCT07749612

Overview

NCT ID: NCT07749612
Lead Sponsor: Bangladesh Medical UniversityOTHER
Official Title: Feasibility, Safety and Efficacy of ZEPU-2000A, ZEPU-2000D and ZEPU-2000E Upper and Lower Limb Active and Passive Rehabilitation Trainer Systems in Patients With Upper and Lower Limb Motor Dysfunction
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 6, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Oct 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 36Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Md. Abdus Shakoor, Ph.D.Contact
shakoorma@bmu.ac.bd

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