ZEPU-2000 robotic rehab for arm and leg weakness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized trial evaluates the feasibility, safety, and preliminary effectiveness of three ZEPU-2000 robotic trainers (upper limb, lower limb gait/mobility, and multifunctional) when added to conventional rehabilitation. Participants are adults 18-60 with arm and/or leg motor impairment, randomized to robotic-assisted rehabilitation plus usual care versus usual care alone. Outcomes focus on safety, tolerance, adherence, and changes in muscle strength, joint movement, balance, walking, and daily function. The study addresses implementation in a LMIC setting and aims to inform a future adequately powered trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Bangladesh Medical University
  Dhaka, Bangladesh Recruiting

Study contacts

• Principal investigator: Md. Abdus Shakoor, Ph.D. — Bangladesh Medical University
• Study coordinator: Md. Abdus Shakoor, Ph.D.
• Email: shakoorma@bmu.ac.bd
• Phone: +8801819410080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.