Hand Related Injuries Clinical Trial
Official title:
The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores
| NCT number | NCT02098564 |
| Other study ID # | REHAB123 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2014 |
| Est. completion date | December 2017 |
| Verified date | August 2018 |
| Source | Odense University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 504 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Odense University Hospital | Odense |
| Lead Sponsor | Collaborator |
|---|---|
| Odense University Hospital | Bevica Fonden, Danish Association of Occupational Therapist, Region of Southern Denmark, University of Southern Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disabilities of the Arm, Shoulder, and Hand questionnaire | from baseline to 12 months after start of rehabilitation | ||
| Secondary | The EQ-5D Quality of life questionnaire | From baseline to 3 months | ||
| Secondary | Sense of Coherence Questionnaire | 13 items questionnaire | From baseline to 12 months | |
| Secondary | Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM) | From baseline to 3 months | ||
| Secondary | Satisfaction with daily living and rehabilitation | From baseline to12 months |