- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02098564
The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores
Background Patients with the same type of hand injury often reach different functional levels. Therefore, it is necessary to investigate what kind of rehabilitation is most efficient for each individual patient.
Research has shown that a person's "Sense of Coherence" (SOC) affects how he /she deals with disease. Furthermore, SOC can help predict final outcomes after orthopedic injuries and should therefore; be taken into consideration when planning rehabilitation. It was concluded in a study that patients with a weak SOC who have had a hand injury, may benefit from extra support to manage their everyday activities in order to reach the same final outcome as patients with a strong SOC.
Purpose To investigate two types of rehabilitation on patients with a hand-related injury (joint mobility exercises vs. activity-based training and joint mobility exercises) and to investigate whether SOC can be used as an indicator of which patients would benefit from activity-based training.
Hypotheses
- Patients with a hand-related injury will benefit from activity-based training in their rehabilitation program.
- Patients with a weak SOC will achieve the best functional level, if activity-based training is included in their rehabilitation program.
- Patients with a strong SOC will not achieve a higher functional level, if activity-based training is included in their rehabilitation program.
Study design Randomised control trial. Methods Four-hundred-twenty- patients age 18 years or older are included when referred to specialized outpatient occupational therapy after a hand-related injury. To ensure sufficient and balanced patient variation in relation to pre-rehabilitation sense of coherence, a balanced randomisation principle has been implemented.
Data will be collected through questionnaires. The questionnaires measure SOC (13 items version), function (DASH), quality of life (EQ5D) and satisfaction.
All participants will perform joint mobility exercises which are appropriate for their injury. In addition, participants who will be performing activity-based training will train with specific meaningful activities which they performed prior to the hand-related injury.
Clinical relevance The knowledge obtained will be incorporated into the planning of occupational therapy rehabilitation services for this patient group, so that the patients will receive the most optimal conditions in which to achieve their previous level of function after a hand injury.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Odense, 덴마크, 5000
- Odense University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with hand-related diagnoses (acute injuries or elective surgeries)
- Patients referred to specialized outpatient occupational therapy rehabilitation at Odense University Hospital
- Patients who are able to understand, speak and read enough Danish to participate
- 18-years of age or older
Exclusion Criteria:
- A rehabilitation treatment period under four weeks and less than three treatments
- Dementia or cognitive impairments
- Where it is not considered medically or therapeutically safe to allow the patient to be included in the randomization process.
- Patients with shoulder problems
- Patients with epicondylitis
- Patients with plexus brachialis injuries
- Patients who only have difficulty extending their non-dominant 5th finger.
- Burn injuries
- Pt. who have had a CMP joint replacement operation because of arthrosis (Swanson)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: strong sense of coherence control group
Patients with a strong sense of coherence.
Participants will perform joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program.
|
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
|
실험적: strong sense of coherence intervention
Patients with a strong sense of coherence.
Participants will perform joint mobility exercises which are appropriate for their injury and specific meaningful activities which they performed prior to the hand-related injury.
This will be performed both in the therapy setting and as a home exercise program.
|
intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury.
Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
|
활성 비교기: weak sense of coherence control group
Patients with a weak sense of coherence.
Participants will perform joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program.
|
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
|
실험적: weak sense of coherence intervention
Patients with a weak sense of coherence.
Participants will perform joint mobility exercises which are appropriate for their injury and specific meaningful activities which they performed prior to the hand-related injury.
This will be performed both in the therapy setting and as a home exercise program.
|
intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury.
Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
|
실험적: medium sense of coherence intervention
Patients with a medium sense of coherence.
Participants will perform joint mobility exercises which are appropriate for their injury and specific meaningful activities which they performed prior to the hand-related injury.
This will be performed both in the therapy setting and as a home exercise program.
|
intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury.
Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
|
활성 비교기: medium sense of coherence control group
Patients with a weak sense of coherence.
Participants will perform joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program.
|
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Disabilities of the Arm, Shoulder, and Hand questionnaire
기간: from baseline to 12 months after start of rehabilitation
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from baseline to 12 months after start of rehabilitation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The EQ-5D Quality of life questionnaire
기간: From baseline to 3 months
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From baseline to 3 months
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Sense of Coherence Questionnaire
기간: From baseline to 12 months
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13 items questionnaire
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From baseline to 12 months
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Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
기간: From baseline to 3 months
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From baseline to 3 months
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Satisfaction with daily living and rehabilitation
기간: From baseline to12 months
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From baseline to12 months
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Hans B Tromborg, Ph.D, University of Southern Denmark
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- REHAB123
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