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临床试验/NCT02098564
NCT02098564已完成不适用

The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 504 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
504
试验地点
1
主要终点
Disabilities of the Arm, Shoulder, and Hand questionnaire

研究概览

简要总结

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

  1. Patients with a hand-related injury will benefit from activity-based training in their rehabilitation program.
  2. Patients with a weak SOC will achieve the best functional level, if activity-based training is included in their rehabilitation program.
  3. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

strong sense of coherence control group

Active Comparator

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.

干预措施: Joint mobility exercises hand therapy (Other)

strong sense of coherence intervention

Experimental

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.

干预措施: activity-based hand therapy (Other)

weak sense of coherence control group

Active Comparator

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.

干预措施: Joint mobility exercises hand therapy (Other)

weak sense of coherence intervention

Experimental

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.

干预措施: activity-based hand therapy (Other)

medium sense of coherence intervention

Experimental

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.

干预措施: activity-based hand therapy (Other)

medium sense of coherence control group

Active Comparator

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.

干预措施: Joint mobility exercises hand therapy (Other)

结局指标

主要结局

Disabilities of the Arm, Shoulder, and Hand questionnaire

时间窗: from baseline to 12 months after start of rehabilitation

次要结局

  • Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)(From baseline to 3 months)
  • The EQ-5D Quality of life questionnaire(From baseline to 3 months)
  • Sense of Coherence Questionnaire(From baseline to 12 months)
  • Satisfaction with daily living and rehabilitation(From baseline to12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alice Ørts Hansen

OT, Master in health science, Ph.D. student

Odense University Hospital

研究点 (1)

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