The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores
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
- Patients with a hand-related injury will benefit from activity-based training in their rehabilitation program.
- Patients with a weak SOC will achieve the best functional level, if activity-based training is included in their rehabilitation program.
- 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Odense, Denemarken, 5000
- Odense University Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
|
|
Experimenteel: 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.
|
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.
|
|
Actieve vergelijker: 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.
|
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
|
|
Experimenteel: 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.
|
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.
|
|
Experimenteel: 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.
|
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.
|
|
Actieve vergelijker: 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.
|
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Disabilities of the Arm, Shoulder, and Hand questionnaire
Tijdsspanne: from baseline to 12 months after start of rehabilitation
|
from baseline to 12 months after start of rehabilitation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The EQ-5D Quality of life questionnaire
Tijdsspanne: From baseline to 3 months
|
From baseline to 3 months
|
|
|
Sense of Coherence Questionnaire
Tijdsspanne: From baseline to 12 months
|
13 items questionnaire
|
From baseline to 12 months
|
|
Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
Tijdsspanne: From baseline to 3 months
|
From baseline to 3 months
|
|
|
Satisfaction with daily living and rehabilitation
Tijdsspanne: From baseline to12 months
|
From baseline to12 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Hans B Tromborg, Ph.D, University of Southern Denmark
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REHAB123
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .