Clinical trial NCT02098564: The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores
Official title: The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Related Injuries
Keywords: hand therapy
activity-based training
hand related injuries
sense of coherence
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Region of Southern Denmark
name: Bevica Fonden
name: Danish Association of Occupational Therapist
First posted: 2014-03-28
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand questionnaire
timeFrame: from baseline to 12 months after start of rehabilitation
Secondary outcomes:
measure: The EQ-5D Quality of life questionnaire
timeFrame: From baseline to 3 months
measure: Sense of Coherence Questionnaire
timeFrame: From baseline to 12 months
measure: Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
timeFrame: From baseline to 3 months
measure: Satisfaction with daily living and rehabilitation
timeFrame: From baseline to12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: University of Southern Denmark
name: Hans B Tromborg, Ph.D
role: STUDY_CHAIR
References: