- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07725744
Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke
2026년 7월 21일 업데이트: National University of Malaysia
Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke: A Prospective, Participant-Blinded, Three-Arm, Parallel-Group Randomized Controlled Trial
This study aims to investigate the interface pressure changes of single-layer with 10% circumferential reduction (S-10), single-layer with 15% circumferential reduction (S-15), and dorsal double-layered with 10% circumferential reduction (DD-10)pressure garments over time, their relationships with adherence and adverse events, and their effects on tactile gnosis.
Participants will:
- Wear S-10, S-15, or DD-10 for at least 12 hours daily for four weeks
- Measure interface pressure at baseline and weekly
- Assess tactile gnosis at baseline, Week 2, and Week 4
- Record adherence and adverse events using a self-report logbook
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
33
단계
- 해당 없음
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:
- adults aged between 21 years to 60 years old
- a history of stroke (no restrictions on the stroke type)
- Modified Ashworth Scale of 1, 1+ or 2 when hand performing flexion and extension
- no cognitive impairment (Montreal Cognitive Assessment (MoCA ⩾ 21)
Exclusion Criteria:
- skin lesions, infections or other skin problems
- serious circulatory problems such as deep vein thrombosis
- hypersensitive to Lycra materials
- behavioural disturbances or motor impairments caused by other orthopaedic or neurological conditions other than 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 |
|---|---|
|
활성 비교기: Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment
A customized single-layered finger-to-above-elbow (long glove) pressure garment with 10% circumferential reduction.
|
Each participant will receive a single-layered 10% circumferential reduction (S-10) pressure garment, fabricated based on their circumferential measurement.
Participants will receive standardized verbal and written instructions on prescribed wear schedules, donning and doffing techniques, skin inspection, and hygiene.
Caregivers will be trained to assist when required.
Participants will be asked to wear the pressure garment daily for at least 6 hours in the day and 6 hours in the evening for 4 weeks, and to record daily wear in a provided logbook.
All participants will receive usual stroke rehabilitation in addition to the application of the pressure garment.
|
|
실험적: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment
A customized finger-to-above-elbow (long glove) pressure garment with 10% of circumferential reduction.
The design is similar to S-10 except it has an extra layer of fabric on the dorsal aspect that provides more compression.
|
Each participant will receive a dorsal doubled-layered 10% circumferential reduction (DD-10) pressure garment, fabricated based on their circumferential measurement.
Participants will receive standardized verbal and written instructions on prescribed wear schedules, donning and doffing techniques, skin inspection, and hygiene.
Caregivers will be trained to assist when required.
Participants will be asked to wear the pressure garment daily for at least 6 hours in the day and 6 hours in the evening for 4 weeks, and to record daily wear in a provided logbook.
All participants will receive usual stroke rehabilitation in addition to the application of the pressure garment.
|
|
활성 비교기: Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment
A customized single-layered finger-to-above-elbow (long glove) pressure garment with 15% circumferential reduction.
|
Each participant will receive a single-layered 15% circumferential reduction (S-15) pressure garment, fabricated based on their circumferential measurement.
Participants will receive standardized verbal and written instructions on prescribed wear schedules, donning and doffing techniques, skin inspection, and hygiene.
Caregivers will be trained to assist when required.
Participants will be asked to wear the pressure garment daily for at least 6 hours in the day and 6 hours in the evening for 4 weeks, and to record daily wear in a provided logbook.
All participants will receive usual stroke rehabilitation in addition to the application of the pressure garment.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Interface pressure measured using PicoPress® Compression System
기간: Baseline, Week-1, Week-2, Week-3, and Week-4
|
The change in interface pressure over time and the group-by-time difference in pressure trajectories among the three pressure garment groups.
PicoPress® Compression System is a portable pneumatic measuring system designed to measure interface pressure exerted by pressure garment, medical compression bandage or other compression therapeutic materials.
|
Baseline, Week-1, Week-2, Week-3, and Week-4
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Shape/Texture Identification (STI) test
기간: Baseline, Week-2, and Week-4
|
A standardized, performance-based test in which participants identify shapes and textures using active touch.
It consists of two subsets (i.e., identification of three shapes and identification of three textures) and three difficulty levels (i.e., shape sizes of 15, 8, and 5mm, and distances between dots of 15, 8, 4mm).
Each subset is scored from 0 to 3 (one point per size), producing a total score that ranges from 0 to 6.
A score of 6 points is interpreted as normal tactile gnosis.
|
Baseline, Week-2, and Week-4
|
|
Daily Self-Report and Adverse Events of Special Interest (AESI) Logbook
기간: Completed by participants or caregiver daily, reviewed weekly by researcher
|
The self-developed logbook is a self-report records that will be used to record the adherence metrics (e.g., daily wear duration, number of days worn per week, reason of non-adherence) and the incidence of adverse events (e.g., incidence, severity, action taken).
|
Completed by participants or caregiver daily, reviewed weekly by researcher
|
|
Modified Ashworth Score (MAS)
기간: Baseline, Week-1, Week-2, Week-3, and Week-4
|
To differentiate between mechanical garment decay and physiological fluctuations in limb volume, muscle tone (spasticity) will be monitored as a potential confounding variable.
|
Baseline, Week-1, Week-2, Week-3, and Week-4
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) - Bahasa Malaysia version
기간: Prior to participant enrolment
|
A widely used screening tool for detecting cognitive impairment, particularly mild cognitive impairment.
It is a 10-minute, 30-point assessment that evaluates various cognitive domains, including working memory, delayed recall, visuospatial abilities, executive functions, attention, concentration, language, and orientation to time and place.
|
Prior to participant enrolment
|
|
Modified Ashworth Score (MAS)
기간: Prior to participant enrolment
|
A method used to assess muscle tone by a scale of 0 to 4, where 0 indicates no spasticity and 4 indicates severe spasticity.
|
Prior to participant enrolment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (추정된)
2026년 7월 20일
기본 완료 (추정된)
2027년 1월 31일
연구 완료 (추정된)
2027년 3월 31일
연구 등록 날짜
최초 제출
2026년 7월 21일
QC 기준을 충족하는 최초 제출
2026년 7월 21일
처음 게시됨 (실제)
2026년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 21일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- JEP-2025-586
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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. .