ZEPU AI9 Exoskeleton Rehabilitation Robot
Feasibility, Safety and Efficacy of ZEPU AI9 Lower Limb Exoskeleton Rehabilitation Robot in Patients With Lower Limb Motor Dysfunction
The goal of this clinical trial is to learn whether the ZEPU AI9 lower limb exoskeleton robot is feasible, safe, and effective for people with walking difficulty caused by stroke, incomplete spinal cord injury, or orthopedic surgery. The main questions it aims to answer are:
Is exoskeleton-assisted gait training well tolerated, and how often do device-related problems (such as falls, pain, or skin injury) occur? Does adding exoskeleton training to usual rehabilitation improve walking distance, walking speed, balance, muscle strength, and joint movement compared with usual rehabilitation alone? Is it practical to add this robotic training into the rehabilitation program at Bangladesh Medical University?
Researchers will compare a group receiving exoskeleton-assisted gait training plus standard rehabilitation to a group receiving standard rehabilitation alone, to see whether the exoskeleton adds benefit.
Participants will:
Be randomly assigned to either the exoskeleton group or the standard-care group If assigned to the exoskeleton group, attend 45-minute training sessions 3 times a week for 12 weeks, supervised by physical therapists with safety harness support Both groups will continue their usual rehabilitation therapy throughout the study Undergo walking, balance, strength, and quality-of-life assessments at the start of the study and every 2 weeks for 12 weeks Be monitored for any side effects or safety concerns during and after each session
調査の概要
状態
詳細な説明
Lower-limb motor dysfunction following stroke, incomplete spinal cord injury, and orthopedic surgery is a major contributor to disability in low- and middle-income countries, where access to intensive, repetitive gait training is often limited by shortages of rehabilitation professionals and structured multidisciplinary programs. Robotic-assisted gait training has emerged as a way to deliver consistent, task-specific, and intensity-controlled practice that is difficult to achieve with therapist-delivered conventional therapy alone, by enabling programmable gait cycles with controlled step length, cadence, symmetry, and body-weight support.
The ZEPU-AI9 is a dual-leg, passive-training lower-limb exoskeleton (Shandong Zepu Medical Technology Co., Ltd.) that generates repeated physiological gait cycles through motorized hip and knee joints while maintaining ankle alignment within a controlled range. It supports standing, sitting, stepping-in-place, and over-ground walking modes via a touchscreen interface and handheld steering joystick, with adjustable thigh/calf length, height, waist width, joint movement angles, step length, and training duration to accommodate individual anthropometrics. Built-in safety features include an emergency stop, automated spasm protection, mechanical joint limits, overload detection, low-battery alarms, and anti-tilt protection, supplemented by an overhead fall-arrest harness during supervised sessions. Powered lower-extremity exoskeletons are classified as Class II medical devices by the U.S. FDA (product code PHL), reflecting both their therapeutic potential and the need for supervised clinical use and standardized protocols. No clinical data on the ZEPU-AI9 currently exist from Bangladesh, and its performance within a Bangladeshi rehabilitation setting has not been evaluated.
This single-site pilot randomized controlled trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Following screening and informed consent, eligible participants will be randomized to receive either ZEPU-AI9-assisted gait training in addition to standard-of-care rehabilitation, or standard-of-care rehabilitation alone, over a 12-week intervention period. Exoskeleton sessions will be conducted three times weekly (45 minutes each, comprising warm-up, device donning, structured gait training, and cool-down), supervised by physiatrists and physiotherapists trained in robotic rehabilitation, with training parameters progressively adjusted based on participant performance and tolerance. Pre- and post-session safety checks (vital signs, skin integrity, pain/fatigue via VAS) will be performed at every session, with device-related adverse events recorded in real time.
Standardized assessments (6-Minute Walk Test, Manual/MRC Muscle Strength Testing, Functional Ambulation Category, Berg Balance Scale, Timed Up and Go test, Modified Ashworth Scale, and a validated Bengali quality-of-life measure) will be administered at baseline and at two-week intervals through week 12, allowing paired comparison of pre- and post-intervention values. Feasibility will additionally be evaluated through recruitment and screening metrics, session adherence and dropout rates, therapist training time, device set-up and donning/doffing time, and a Post-Study System Usability Questionnaire administered at study completion.
Data will be analyzed on an intention-to-treat basis (all randomized participants analyzed per original group assignment), with a secondary per-protocol analysis restricted to participants completing the intervention as specified. Continuous variables will be summarized as mean ± SD (or median/IQR where non-normally distributed) and compared using paired or unpaired t-tests, or Wilcoxon signed-rank tests as appropriate, with statistical significance set at p<0.05. Findings from this pilot study are intended to generate feasibility indicators and preliminary effect-size estimates to inform the design of a future, adequately powered randomized controlled trial and to guide national implementation strategies for robotic rehabilitation in Bangladesh.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Md. Abdus Shakoor, Ph.D.
- 電話番号：+8801819410080
- メール：shakoorma@bmu.ac.bd
研究場所
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Dhaka、バングラデシュ、1000
- 募集
- Bangladesh Medical University
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コンタクト：
- Md. Abdus Shakoor, Ph.D.
- 電話番号：+8801819410080
- メール：shakoorma@bmu.ac.bd
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age ≥ 18 and ≤ 60 years.
- Lower-limb motor dysfunction from one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal-cord injury (neurological level T12 and below, ASIA C or D), (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment > 3months post-surgery.
- Able to provide informed consent and understand instructions.
- Weight ≤ 100 kg (as per device spec) and height within device adjustable range (manufacturer spec).
- Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, untreated DVT) with necessary investigations.
Exclusion Criteria:
- Complete spinal cord injury with inability to bear any weight.
- Severe cognitive impairment (e.g., MMSE < 24) preventing safe participation.
- Severe spasticity (Modified Ashworth Scale > 3) in lower limbs.
- Unstable fractures, severe hip/knee contractures (> 30° fixed flexion), severe osteoarthritis requiring imminent surgery.
- Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors.
- Pregnancy.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Robotic-Augmented Rehabilitation Group
Participants will receive ZEPU-AI9 exoskeleton-assisted gait training in addition to standard-of-care rehabilitation.
Exoskeleton sessions will be conducted 3 times per week for 12 weeks (45 minutes/session, including donning, warm-up, structured gait training, and cool-down), supervised by trained physiatrists and physiotherapists with safety harness support.
Training parameters will be progressively adjusted based on participant performance and tolerance.
Standard rehabilitation (balance training, lower-limb strengthening, stretching, gait retraining) will continue in parallel per institutional protocol.
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A powered, dual-leg lower-limb exoskeleton (Shandong Zepu Medical Technology Co., Ltd.) that generates repeated physiological gait cycles via motorized hip and knee joints, supporting standing, sitting, stepping-in-place, and over-ground walking.
Adjustable thigh/calf length, height, waist width, joint angles, step length, and training duration accommodate individual anthropometrics.
Participants will use the device 3 times per week for 12 weeks (45-minute sessions), supervised by trained physiatrists/physiotherapists, with an overhead safety harness.
Training parameters are progressively adjusted based on performance.
Safety features include emergency stop, automated spasm protection, mechanical joint limits, overload detection, and anti-tilt protection.
Used in addition to standard-of-care rehabilitation.
Institutional standard rehabilitation therapy delivered by physiotherapists, comprising balance training, lower-limb strengthening exercises, stretching, and gait retraining, per Department of Physical Medicine and Rehabilitation protocol at Bangladesh Medical University.
Received by all participants throughout the 12-week study period, either alone (Usual Care Group) or in combination with ZEPU-AI9 exoskeleton-assisted gait training (Robotic-Augmented Rehabilitation Group).
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アクティブコンパレータ：Usual Care Group
Participants will receive standard-of-care rehabilitation alone (balance training, lower-limb strengthening, stretching, gait retraining) per institutional protocol, without ZEPU-AI9 exoskeleton-assisted training, over the 12-week study period.
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Institutional standard rehabilitation therapy delivered by physiotherapists, comprising balance training, lower-limb strengthening exercises, stretching, and gait retraining, per Department of Physical Medicine and Rehabilitation protocol at Bangladesh Medical University.
Received by all participants throughout the 12-week study period, either alone (Usual Care Group) or in combination with ZEPU-AI9 exoskeleton-assisted gait training (Robotic-Augmented Rehabilitation Group).
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Device-Related Adverse Events and Serious Adverse Events
時間枠：Baseline (T0) to 12 weeks, assessed at 2-week intervals
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Number and proportion 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, during the 12-week intervention and follow-up period.
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Baseline (T0) to 12 weeks, assessed at 2-week intervals
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Device Tolerability
時間枠：Baseline (T0) to 12 weeks, assessed at 2-week intervals
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Tolerability of ZEPU-AI9 exoskeleton training assessed as the number of sessions completed versus sessions planned, number of participant dropouts, and reasons for dropout, during the 12-week intervention period.
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Baseline (T0) to 12 weeks, assessed at 2-week intervals
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Walking Distance on 6-Minute Walk Test
時間枠：Baseline (T0) to 12 weeks, assessed at 2-week intervals
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Distance walked (in meters) in 6 minutes, used to assess functional exercise capacity and gait endurance.
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Baseline (T0) to 12 weeks, assessed at 2-week intervals
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Change in Lower-Limb Muscle Strength (MRC Scale)
時間枠：Baseline (T0) to 12 weeks, assessed at 2-week intervals]
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Lower-limb muscle strength assessed using the Medical Research Council (MRC) Muscle Strength Scale, graded 0-5 for key muscle groups.
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Baseline (T0) to 12 weeks, assessed at 2-week intervals]
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Change in Functional Ambulation Category (FAC) Score
時間枠：Baseline (T0) to 12 weeks, assessed at 2-week intervals]
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Level of walking independence assessed using the Functional Ambulation Category, scored 0 (non-ambulatory) to 5 (independent on all surfaces).
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Baseline (T0) to 12 weeks, assessed at 2-week intervals]
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Change in Berg Balance Scale (BBS) Score
時間枠：Baseline (T0) to 12 weeks, assessed at 2-week intervals
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Balance ability assessed using the Berg Balance Scale, a 14-item performance-based measure scored 0-56, with higher scores indicating better balance.
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Baseline (T0) to 12 weeks, assessed at 2-week intervals
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Change in Timed Up and Go (TUG) Test
時間枠：Baseline and every 2 weeks through 12 weeks
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Time (in seconds) taken to rise from a chair, walk 3 meters, turn, walk back, and sit down, used to assess functional mobility and fall risk.
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Baseline and every 2 weeks through 12 weeks
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Change in Lower-Limb Spasticity (Modified Ashworth Scale)
時間枠：Baseline and every 2 weeks through 12 weeks
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Muscle tone and spasticity in the lower limbs assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale (0 to 4, including 1+).
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Baseline and every 2 weeks through 12 weeks
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Change in Quality of Life (EuroQol Questionnaire)
時間枠：Baseline and every 2 weeks through 12 weeks
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Health-related quality of life assessed using the EuroQol (EQ-5D) questionnaire, validated Bengali version, covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
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Baseline and every 2 weeks through 12 weeks
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協力者と研究者
捜査官
- 主任研究者：Md. Abdus Shakoor, Ph.D.、Bangladesh Medical University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PR-1422
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