CClinicalTrials.gg
CompletedNCT02098564Updated Aug 31, 2018

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

An interventional study of Joint mobility exercises hand therapy and activity-based hand therapy in Hand Related Injuries, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.

Sponsored by Odense University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
504
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hand Related Injuries

Browse trials for

Keywords

  • hand therapy
  • activity-based training
  • hand related injuries
  • sense of coherence
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 504 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
504 participants (actual)

Study arms

  • Active comparator
    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.

    Other: Joint mobility exercises hand therapy

  • Experimental
    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.

    Other: activity-based hand therapy

  • Active comparator
    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.

    Other: Joint mobility exercises hand therapy

  • Experimental
    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.

    Other: activity-based hand therapy

  • Experimental
    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.

    Other: activity-based hand therapy

  • Active comparator
    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.

    Other: Joint mobility exercises hand therapy

Interventions

  • OtherJoint mobility exercises hand therapy

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

  • Otheractivity-based hand therapy

    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.

06

What researchers measure

Primary outcomes

  1. Disabilities of the Arm, Shoulder, and Hand questionnaire

    Time frame: from baseline to 12 months after start of rehabilitation

Secondary outcomes

  1. The EQ-5D Quality of life questionnaire

    Time frame: From baseline to 3 months

  2. Sense of Coherence Questionnaire

    13 items questionnaire

    Time frame: From baseline to 12 months

  3. Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)

    Time frame: From baseline to 3 months

  4. Satisfaction with daily living and rehabilitation

    Time frame: From baseline to12 months

07

Study locations

1 site
  • Odense University Hospital
    Odense, 5000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02098564
Lead sponsor
Odense University Hospital
Collaborators
University of Southern Denmark, Region of Southern Denmark, Bevica Fonden, Danish Association of Occupational Therapist
Responsible party
Alice Ørts Hansen (OT, Master in health science, Ph.D. student, Odense University Hospital) — Principal investigator
First posted
Mar 28, 2014
Start date
Feb 2014
Primary completion
Dec 2016
Completion
Dec 2017
Last update
Aug 31, 2018

Study contacts

Hans B Tromborg, Ph.D
study chair · University of Southern Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion