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

NCT ID: NCT02098564

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

Hand Related Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Joint mobility exercises hand therapy

Intervention Type: OTHER

Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program

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.

Group Type: EXPERIMENTAL

activity-based hand therapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Joint mobility exercises hand therapy

Intervention Type: OTHER

Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program

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.

Group Type: EXPERIMENTAL

activity-based hand therapy

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

activity-based hand therapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Joint mobility exercises hand therapy

Intervention Type: OTHER

Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program

Interventions

Joint mobility exercises hand therapy

Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program

Intervention Type: OTHER

activity-based hand therapy

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

Bevica Fonden

OTHER

Sponsor Role: collaborator

Danish Association of Occupational Therapist

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alice Ørts Hansen

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans B Tromborg, Ph.D

Role: STUDY_CHAIR

University of Southern Denmark

Locations

Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

REHAB123

Identifier Type: -

Identifier Source: org_study_id