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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

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

    Time frame: From baseline to 12 months

    13 items questionnaire

  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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Bevica Fonden
  • Danish Association of Occupational Therapist
  • Region of Southern Denmark
  • University of Southern Denmark

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 28, 2014
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.