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

NCT02098564 | Completed

• 1 other identifier: REHAB123
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

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. 1.Patients with a hand-related injury will benefit from activity-based training in their rehabilitation program.
2. 2.Patients with a weak SOC will achieve the best functional level, if activity-based training is included in their rehabilitation program.
3. 3.Patients with a strong SOC will not achieve a higher functional level, if activity-based training is included in their rehabilitation program.

Conditions

Hand Related Injuries

Keywords

hand therapy; activity-based training; hand related injuries; sense of coherence

Outcome Measures

Primary Outcomes (1)

• Disabilities of the Arm, Shoulder, and Hand questionnaire

  from baseline to 12 months after start of rehabilitation

Secondary Outcomes (4)

• The EQ-5D Quality of life questionnaire

  From baseline to 3 months

• Sense of Coherence Questionnaire

  From baseline to 12 months

• Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)

  From baseline to 3 months

• Satisfaction with daily living and rehabilitation

  From baseline to12 months

Study Arms (6)

strong sense of coherence control group

ACTIVE COMPARATOR

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.

Other: Joint mobility exercises hand therapy

strong sense of coherence intervention

EXPERIMENTAL

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.

Other: activity-based hand therapy

weak sense of coherence control group

ACTIVE COMPARATOR

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.

Other: Joint mobility exercises hand therapy

weak sense of coherence intervention

EXPERIMENTAL

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.

Other: activity-based hand therapy

medium sense of coherence intervention

EXPERIMENTAL

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.

Other: activity-based hand therapy

medium sense of coherence control group

ACTIVE COMPARATOR

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.

Other: Joint mobility exercises hand therapy

Interventions

Joint mobility exercises hand therapy OTHER

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

medium sense of coherence control group; strong sense of coherence control group; weak sense of coherence control group

activity-based hand therapy 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; strong sense of coherence intervention; weak sense of coherence intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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)

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• Region of Southern Denmark: collaborator
• Bevica Fonden: collaborator
• Danish Association of Occupational Therapist: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Study Officials

• Hans B Tromborg, Ph.D

  University of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OT, Master in health science, Ph.D. student

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 28, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

DK (1)