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
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 and Serious Adverse Events
研究概览
简要总结
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
详细描述
This is a pilot randomized controlled trial evaluating the feasibility, safety, and preliminary efficacy of three robotic upper and lower limb rehabilitation trainer systems - ZEPU-2000A (upper limb trainer), ZEPU-2000D (lower limb gait and mobility trainer), and ZEPU-2000E (multifunctional upper and lower limb trainer) - when added to conventional rehabilitation, compared with conventional rehabilitation alone, in adults with upper and/or lower limb motor dysfunction.
Rationale: Upper- and lower-limb motor dysfunction following stroke, incomplete spinal cord injury, traumatic brain injury, and orthopedic conditions is a major cause of long-term disability. Motor recovery is closely linked to repetitive, task-specific, goal-oriented movement practice, but conventional therapist-led rehabilitation is often limited by therapist availability, fatigue, and variability in delivery. Electromechanical and robotic trainer systems can deliver standardized, repetitive, programmable movement training with objective performance monitoring across passive, active-assisted, and active-resisted modes. While robotic rehabilitation has shown benefit in high-income settings, evidence on feasibility, safety, and effectiveness in low- and middle-income countries remains limited. This study will generate local evidence to support the integration of the ZEPU-2000 series into rehabilitation services at Bangladesh Medical University (BMU) and to inform the design of a future adequately powered trial.
Setting: Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University, Dhaka, Bangladesh. Devices are provided and supported by the manufacturer (Shandong ZEPU Medical Technology Co. Ltd) through an approved distributor. Sessions are conducted under the supervision of physiatrists and physiotherapists.
Design: Thirty-six participants will be enrolled for each robotic system and randomized 1:1 into two arms:
Intervention arm (Robotic-Augmented Rehabilitation Group): standard-of-care rehabilitation plus robotic-assisted therapy using the ZEPU-2000A, ZEPU-2000D, or ZEPU-2000E systems.
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: 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
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 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
研究组 & 干预措施
Robotic-Augmented Rehabilitation Group
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.
干预措施: ZEPU-2000A (Device)
Robotic-Augmented Rehabilitation Group
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.
干预措施: Standard Rehabilitation Care (Behavioral)
Robotic-Augmented Rehabilitation Group
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.
干预措施: ZEPU-2000D (Device)
Robotic-Augmented Rehabilitation Group
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.
干预措施: ZEPU-2000E (Device)
Usual Care Group
Participants receive standard-of-care rehabilitation alone, including individualized rehabilitation and exercise (e.g., strengthening, balance training, stretching, gait retraining), without robotic-assisted therapy.
干预措施: Standard Rehabilitation Care (Behavioral)
结局指标
主要结局
Incidence of Device-Related Adverse Events and Serious Adverse Events
时间窗: Baseline (T=0) up to 12 weeks, assessed every 2 weeks
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.
Device Tolerability
时间窗: Baseline (T=0) up to 12 weeks, assessed every 2 weeks
Number of training sessions completed relative to sessions planned, and number of participant drop-outs with reasons for discontinuation.
次要结局
- 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)
- Change in Upper Limb Motor Function(Baseline (T=0) to 12 weeks, assessed every 2 weeks)
- Change in Activities of Daily Living(Baseline (T=0) to 12 weeks, assessed every 2 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