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

Primary Purpose

Hand Related Injuries

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Joint mobility exercises hand therapy
activity-based hand therapy
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Related Injuries focused on measuring hand therapy, activity-based training, hand related injuries, sense of coherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

strong sense of coherence control group

strong sense of coherence intervention

weak sense of coherence control group

weak sense of coherence intervention

medium sense of coherence intervention

medium sense of coherence control group

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Disabilities of the Arm, Shoulder, and Hand questionnaire

Secondary Outcome Measures

The EQ-5D Quality of life questionnaire
Sense of Coherence Questionnaire
13 items questionnaire
Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
Satisfaction with daily living and rehabilitation

Full Information

First Posted
March 21, 2014
Last Updated
August 30, 2018
Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark, Region of Southern Denmark, Bevica Fonden, Danish Association of Occupational Therapist
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1. Study Identification

Unique Protocol Identification Number
NCT02098564
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark, Region of Southern Denmark, Bevica Fonden, Danish Association of Occupational Therapist

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Related Injuries
Keywords
hand therapy, activity-based training, hand related injuries, sense of coherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
strong sense of coherence control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
strong sense of coherence intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
weak sense of coherence control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
weak sense of coherence intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
medium sense of coherence intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
medium sense of coherence control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Joint mobility exercises hand therapy
Intervention Description
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
Intervention Type
Other
Intervention Name(s)
activity-based hand therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder, and Hand questionnaire
Time Frame
from baseline to 12 months after start of rehabilitation
Secondary Outcome Measure Information:
Title
The EQ-5D Quality of life questionnaire
Time Frame
From baseline to 3 months
Title
Sense of Coherence Questionnaire
Description
13 items questionnaire
Time Frame
From baseline to 12 months
Title
Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
Time Frame
From baseline to 3 months
Title
Satisfaction with daily living and rehabilitation
Time Frame
From baseline to12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans B Tromborg, Ph.D
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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

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