Robotic-Assisted Training on Hand Function in Stroke
2026년 7월 8일 업데이트: Adly A Adam
Robotic-Assisted Training on Hand Function in Stroke Patient
Stroke is a neurological deficit attributed to an acute focal injury of the central nervous system.
A key component of stroke rehabilitation is improving upper limb function to reduce impairments and disabilities.
A task-specific approach retraining for upper extremity control seeks to minimize impairments while maximizing the patient's functional performance.
Technology-supported training is emerging to help therapists, patients, and the health system.
Robotic devices allow to facilitate and control the complexity of a motor task.
The benefits of robotic rehabilitation affect both therapists and patients: robot-assisted therapy can increase treatment compliance by way of introducing games or interactive upper limb tasks and patients can train independently with less supervision from therapists.
Therefore, this study was conducted in line to determine the effect of robotic-assisted training on hand function in patients following a stroke.
연구 개요
상태
완전한
상세 설명
Stroke is the leading cause of complex adult disability with arm function impairment affecting approximately 69% of stroke survivors.
Enhancing arm function is a priority for stroke survivors, caregivers, and healthcare professionals, as current rehabilitation approaches often neglect arm recovery.
In Motion robotic gym system represents an effective treatment option for improving upper limb function in patients' post-stroke, owing to its ease of application, cost-effectiveness, and tolerability.
Rehabilitation robotics is an emerging research domain aimed at leveraging cutting-edge robotic technology and virtual reality systems for the rehabilitation of neurological patients.
While clinical trials in post-stroke patients with upper limb impairments have yielded positive results regarding motor recovery, they have shown limited efficacy concerning functional outcomes.
Thus, there remains a pressing need to develop a new generation of rehabilitation robots and clinical protocols that can more effectively assist patients in regaining their abilities in activities of daily living.
Therefore, this study was conducted in line to determine the effect of robotic-assisted training 'course of 12 weeks' on hand function 'assessing strength, via dynamometer, function via Fugle-Meyer test, and overall function via Jobson hand function' in patients following a stroke.
연구 유형
중재적
등록 (실제)
34
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Cairo Governorate
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Cairo, Cairo Governorate, 이집트, 11432
- Cairo University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age ranged from 40 to 60 years old.
- Clinical diagnosis of ischemic stroke and diagnosis confirmed by CT or MRI with hand impairments.
- Stroke started since six months (at chronic stage)
- Mild to moderate upper limb functional limitation according to (Fugl-Meyer score: 85-99).
- Ability to understand and follow instructions and to provide informed consent.
Exclusion Criteria:
- More than one stroke.
- Other current significant impairment of the upper limb affected by stroke, e.g. fixed contracture, frozen shoulder, severe arthritis, recent fracture.
- Diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. registered blind.
- Previous use of the InMotion robotic gym system or other arm rehabilitation robot.
- Current participation in a rehabilitation trial evaluating upper limb rehabilitation after stroke
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Study Group (A)
Received Robot-assisted training of a selected physical therapy program using Multifunctional intelligent instrument system for 45 minutes, three times per week, for 12 week.
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The Hand Wrist Assistive Rehabilitation Device or HWARD: 'exoskeleton with 3 degrees of freedom (flexion-extension of the fingers, thumb and wrist) that assists (through pneumatic actuators) the hand in the" grasp and release "movement.
The patient is seated in front of a monitor, the hand is secured to the robot by three soft Velcro strips, The palm of the hand is left free allowing the grasping of real objects, as well as virtual ones.
Its a 45 minutes session , three times per week, for 12 weeks.
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활성 비교기: Control Group (B)
Received Conventional physical therapy program for 1 hour per session, three times per week, for12 weeks.
Passive, active assisted, and active range of motion exercises for affected upper extremity for 30 minutes, Facilitation and inhibition techniques, plus neuromuscular electrical stimulation for wrist extensors for 30 minutes.
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Passive, active-assisted, and active range of motion, and facilitation/inhibition techniques for 30 minutes, also Neuromuscular electrical stimulation for wrist extensors, and task-oriented exercise training for strengthening foe 30 minutes.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hand-held dynamometer for measuring hand strength
기간: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 12 weeks of intervention.
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Handheld dynamometer (Item model number:EH101, Manufacturer: Handeful), it is equipped with high precision strain gauge sensor that provides an accurate momentary digital reading of gripping power with a maximum capacity 198ibs - 90kgm.
It is easy to read as it includes a large LCD screen that displays all measurements.
It is used for measuring hand strength, while patient was seated comfortably, then was asked to place the arms by sides with his\her elbow in a 90-flexion position in neutral, then instructed to squeeze the digital hand dynamometer as hard as possible for 3 seconds, the test was repeated 2 more times and the mean handgrip strength of the 3 attempts were recorded.
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1. Pre-treatment at base-line of the study. 2. Post-treatment after 12 weeks of intervention.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fugl-Meyer Test (Upper limb impairment test)
기간: 1. Pre-treatment at base-line 2. Post-treatment after 12 weeks of intervention
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Fugl-Meyer Test is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
It takes approximately 30-35 minutes, Scoring is based on direct observation of performance.
Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.
The total possible scale score is 226.
Noting 0-35: Very severe, 6-55: Severe, 56-79: Moderate, more than 79 indicates mild in the scoring system.
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1. Pre-treatment at base-line 2. Post-treatment after 12 weeks of intervention
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Jobson Hand function test
기간: 1. Pre-treatment at baseline of the study 2. Post-treatment after 12 weeks of intervention
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It is a health and care, UK, that is a used to evaluate the functional capabilities using a stopwatch.
It includes seven items: picking up small common objects, card turning, simulated feeding (bean spooning), picking up large light objects, stacking checkers, picking up large heavy objects, and writing a short sentence.
The time of performance was recorded for each test.
Total score is the sum of time taken for each sub-test, which are rounded to the nearest second.
Shorter times indicate better performance
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1. Pre-treatment at baseline of the study 2. Post-treatment after 12 weeks of intervention
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Jobson Hand function test
기간: 1. Pre-Treatment at baseline of the study 2. Post-treatment of 12 weeks of intervention
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Using a stop watch for scoring and evaluating the functional capabilities of patients.
This test includes seven items: picking up small common objects, card turning, simulated feeding (bean spooning), picking up large light objects, stacking checkers, picking up large heavy objects, and writing a short sentence.
The time of performance was recorded for each test Total score is the sum of time taken for each sub-test, which are rounded to the nearest second.
Shorter times indicate better performance.
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1. Pre-Treatment at baseline of the study 2. Post-treatment of 12 weeks of intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 의자: Mushira H Darwish, Professor, Cairo University; Faculty of Physical Therapy
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 5월 1일
기본 완료 (실제)
2026년 3월 1일
연구 완료 (실제)
2026년 5월 30일
연구 등록 날짜
최초 제출
2026년 7월 8일
QC 기준을 충족하는 최초 제출
2026년 7월 8일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 8일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- P.T.REC/012/005776
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 지원 정보 유형
- 연구_프로토콜
- CSR
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
뇌졸중에 대한 임상 시험
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Institut National de la Santé Et de la Recherche...모병