- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03731208
Telerehabilitation of Patients After Knee Surgery
Future Patient - Telerehabilitation of Patients After Knee Surgery
This project is aimed to investigate the feasibility of employing communication and sensor technologies for the patient after a knee operation.
In the study, it is hypothesized that the effectiveness of postoperative rehabilitation programs might be improved by establishing electronic communication between healthcare professionals and the patients. It is also believed that users satisfaction and patients quality of life will be improved.
The telerehabilitation program promises a synchronized communication as well as an individualized training program (by health professionals) based on the patient's electronic reports.
연구 개요
상세 설명
Aim The objectives of this project are to assess the feasibility of using a telerehabilitation program for patients after a knee operation and investigate the acceptance of the provided solution by the patients and healthcare professionals.
Hypothesis It is hypothesized that the acceptance and satisfaction of patients and healthcare professionals by using the telerehabilitation program will be high and correlated with patients' exercise adherence and health recovery.
Telerehabilitation Group (Target Group) The subjects will be recruited before the operation and will be followed during an 8-week rehabilitation period.
In addition to the telerehabilitation program, the subjects will receive the regular treatment offered by Farsø Hospital in connection with total knee replacement surgery and are to follow the same rehabilitation procedure as regular patients (see below).
Before the operation, the project physiotherapist will hand over the telerehabilitation system equipment and instruct the subject how to use the system. In addition, the physiotherapist will also ask the subject to follow the instruction process and try the available services a few times. The physiotherapist makes sure that the subject can operate the system easily and without any challenges.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Aalborg, 덴마크, 9220
- Aalborg University
-
Farsø, 덴마크, 9640
- Aalborg University Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged over 18
- Successful primary total knee replacement surgery at Farsø Hospital
- Referred to the regular rehabilitation program (self-training at home) by the physiotherapists at Farsø Hospital
- Ability to walk (with or without walking aids)
- Able to use electronic technologies and devices (for example: smart phone, tablet) or at least one relative who can assist in this matter
- Living in The North Denmark Region
Exclusion Criteria:
- Previous or current drug addiction defined as the use of cannabis, opioids or other drugs
- Previous or current neurologic, musculoskeletal or mental illnesses
- Any other aggravating medical complication (such as infection or DVT)
- Lack of ability to understand and accept trial procedures
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Intervention group
The patient assign to this arm receive the telerehabilitation program for 8-week after a knee operation
|
The telerehabilitation program equipment consists of the following devices:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Usability of the telerehabilitation program: semi-structured interview
기간: The interview is conducted two weeks after discharge.
|
The data is collected by a semi-structured interview
|
The interview is conducted two weeks after discharge.
|
Exercise adherence
기간: Everyday, started after discharge and for period of 8-weeks
|
Measured by telerehabilitation system reports
|
Everyday, started after discharge and for period of 8-weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Self-reported pain, stiffness, and physical function: KOOS
기간: After discharge (weeks 2, 8)
|
Measured using Knee injury and Osteoarthritis Outcome Score (KOOS)
|
After discharge (weeks 2, 8)
|
Self-reported pain and physical function: OKS
기간: Baseline (before operation), and after discharge (weeks 0,2,4,6,8)
|
measured by an electronic version of Oxford Knee Score (OKS)
|
Baseline (before operation), and after discharge (weeks 0,2,4,6,8)
|
Self-reported pain: VAS
기간: Baseline (before operation), and every third day after discharge (for period of 8 weeks)
|
Measured by an electronic report of the visual analog scale (VAS) of pain [minimum 0, Maximum 10] higher values represent a higher level of pain
|
Baseline (before operation), and every third day after discharge (for period of 8 weeks)
|
Self-reported knee swelling
기간: Baseline (before operation), and every third day after discharge (for period of 8 weeks)
|
measured by an electronic report of knee circumference
|
Baseline (before operation), and every third day after discharge (for period of 8 weeks)
|
Quality of life: EQ-5D
기간: After discharge (weeks 2, 8)
|
Measured using Euro Quality of Life - 5 Dimension (EQ-5D)
|
After discharge (weeks 2, 8)
|
Users satisfaction: semi-structured interview
기간: The interview is conducted two weeks after discharge.
|
Measured by semi-structured interview
|
The interview is conducted two weeks after discharge.
|
공동 작업자 및 조사자
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- N-20180012
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .