- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02098564
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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-
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Odense, Dánia, 5000
- Odense University Hospital
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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)
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: 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
|
|
Kísérleti: 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.
|
|
Aktív összehasonlító: 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
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Aktív összehasonlító: 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
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
|---|---|
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Disabilities of the Arm, Shoulder, and Hand questionnaire
Időkeret: from baseline to 12 months after start of rehabilitation
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from baseline to 12 months after start of rehabilitation
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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The EQ-5D Quality of life questionnaire
Időkeret: From baseline to 3 months
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From baseline to 3 months
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Sense of Coherence Questionnaire
Időkeret: From baseline to 12 months
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13 items questionnaire
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From baseline to 12 months
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Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
Időkeret: From baseline to 3 months
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From baseline to 3 months
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Satisfaction with daily living and rehabilitation
Időkeret: From baseline to12 months
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From baseline to12 months
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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Tanulmányi szék: Hans B Tromborg, Ph.D, University of Southern Denmark
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- REHAB123
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