Feasibility, Safety and Efficacy of ZEPU-SGI1PLUS Hand Functional Comprehensive Training Systems in Patients With Upper Limb Motor Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The goal of this pilot randomized controlled trial is to learn whether the ZEPU-SG1PLUS Hand Functional Comprehensive Training System - a robotic device used alongside standard rehabilitation - is safe, feasible, and helpful for people with upper limb (arm/hand) motor problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic conditions.
The main questions it aims to answer are:
Is robotic-assisted hand training well tolerated by patients, and can it be safely added to standard rehabilitation, with acceptable rates of device-related side effects? Does adding robotic hand training to standard rehabilitation improve arm and hand strength, range of motion, and functional ability compared with standard rehabilitation alone? Is it practical to fit this type of robotic training into everyday rehabilitation services at Bangladesh Medical University?
Researchers will compare a robotic-augmented rehabilitation group to a standard-care (control) group to see whether adding robotic hand training works better than usual rehabilitation alone.
Participants will:
Be randomly assigned to one of two groups: one receiving standard rehabilitation plus robotic hand training with the ZEPU-SG1PLUS device, and one receiving standard rehabilitation alone If assigned to the robotic training group, attend three training sessions per week for 12 weeks, each lasting about 30-45 minutes, at the Robotic Rehabilitation Centre, BMU Undergo assessments at the start of the study and at two-week intervals during the 12-week program and follow-up period, including tests of muscle strength, joint movement, hand function, and daily activity ability Be monitored throughout for any side effects or safety concerns related to the training
详细描述
Upper limb motor dysfunction following stroke, incomplete spinal cord injury, traumatic brain injury, and orthopedic conditions is a major contributor to long-term disability. Conventional rehabilitation, while foundational, is often limited in the intensity, repetition, and task specificity needed to optimally drive neuroplasticity-dependent motor recovery. Electromechanical and robotic rehabilitation systems have emerged as adjuncts capable of delivering standardized, repetitive, programmable movement training with real-time feedback and objective performance monitoring, and evidence from high-income settings suggests such systems can improve motor function and functional outcomes when combined with conventional therapy. However, data on the feasibility, safety, and effectiveness of these technologies in low- and middle-income country (LMIC) settings, including Bangladesh, remain limited.
Bangladesh Medical University (BMU) has recently introduced the ZEPU-SG1PLUS Hand Functional Comprehensive Training System at its Robotic Rehabilitation Centre. Before this technology is integrated more broadly into clinical practice, this pilot study will generate foundational local evidence on its feasibility, safety, and preliminary efficacy, and will inform the design and sample-size estimation of a future adequately powered randomized controlled trial.
Device: The ZEPU-SG1PLUS is a non-powered, mechanically assisted training system built around a stable steel-frame table integrated with twelve dedicated training modules targeting distinct hand and upper-limb movement patterns, including thumb-to-palm motion, wrist flexion-extension, forearm rotation, finger flexion/extension, pinching, side pinching, spherical grip rotation, ulnar/radial deviation, horizontal stretching, and hand lifting. Resistance is provided by an adjustable counterweight system (four independent columns, 250 g increments, 500 g-3000 g range), allowing progressive, individualized resistance training. A tablet-based interactive software interface supports user identification, session setup, timing control, and recording of training activity, with session duration configurable from 1-99 minutes.
Design: This is a pilot randomized controlled trial conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, BMU. Eligible participants (adults with upper-limb motor dysfunction due to stroke, incomplete spinal cord injury, traumatic brain injury, or orthopaedic/post-surgical conditions) will be randomly allocated 1:1 to an Intervention Arm (standard-of-care rehabilitation plus ZEPU-SG1PLUS training) or a Control Arm (standard-of-care rehabilitation alone). Robotic sessions will be delivered 3 times weekly for 12 weeks (30-45 minutes per session), under supervision of physiatrists and physiotherapists, with training parameters progressively adjusted based on individual performance and tolerance. Assessments occur at baseline and at two-week intervals through the intervention and follow-up periods.
Assessment methods: Muscle strength is assessed by Manual Muscle Testing, grip strength by dynamometer, spasticity by the Modified Ashworth Scale, and general health status by the EQ-VAS. Device-recorded training parameters (e.g., repetitions, resistance level, session duration) are captured as objective indicators of rehabilitation progress. Feasibility and usability are evaluated through screening/enrollment flow, session adherence and dropout tracking, therapist training and device set-up time, level of assistance required for donning/doffing, and a Post-Study System Usability Questionnaire administered at study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 (neurological level C5 and below), classified as ASIA Impairment Scale C or D; (c) traumatic brain injury with persistent upper-limb functional limitation; or (d) orthopedic or post-surgical conditions involving the shoulder, elbow, wrist, or hand with persistent functional impairment for > 3 months
- •Age between 18 and 60 years, inclusive
- •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 the ZEPU-SG1PLUS Hand Functional Comprehensive Training System 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
排除标准
- •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 device incompatible with robotic sensors
- •Pregnancy
研究组 & 干预措施
Robotic-Augmented Rehabilitation Group
Participants receive standard-of-care rehabilitation combined with robotic-assisted hand training using the ZEPU-SG1PLUS Hand Functional Comprehensive Training System, 3 sessions per week for 12 weeks (approximately 30-45 minutes per session).
干预措施: Standard-of-Care Rehabilitation (Other)
Standard Care (Control) Group
Participants receive standard-of-care rehabilitation alone, including conventional exercise and wax bath therapy, without the addition of robotic-assisted hand training.
干预措施: Standard-of-Care Rehabilitation (Other)
Robotic-Augmented Rehabilitation Group
Participants receive standard-of-care rehabilitation combined with robotic-assisted hand training using the ZEPU-SG1PLUS Hand Functional Comprehensive Training System, 3 sessions per week for 12 weeks (approximately 30-45 minutes per session).
干预措施: ZEPU-SG1PLUS Hand Functional Comprehensive Training System (Device)
结局指标
主要结局
Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline (Week 0) through end of 12-week intervention and follow-up
Number and proportion of participants experiencing device-related AEs or SAEs, including falls, skin breakdown/pressure sores, joint pain or injury, cardiovascular events, fracture, or device malfunction.
Device Tolerability (Session Completion Rate)
时间窗: 12 weeks
Number of robotic training sessions completed relative to sessions planned; number of participant drop-outs and reasons for drop-out.
次要结局
- Muscle Strength(Baseline and every 2 weeks through 12 weeks)
- Grip Strength(Baseline and every 2 weeks through 12 weeks)
- Upper-Limb Spasticity(Baseline and every 2 weeks through 12 weeks)
- Health-Related Quality of Life(Baseline and every 2 weeks up to 12 weeks)
研究者
Md. Abdus Shakoor, Ph.D.
Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University
Bangladesh Medical University