Hand Related InjuriesNCT02098564
The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores
A study testing Joint mobility exercises hand therapy and activity-based hand therapy in people with Hand Related Injuries, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Related Injuries
- What is being tested?
- Joint mobility exercises hand therapy and activity-based hand therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Hand Related Injuries
- Being tested
- Joint mobility exercises hand therapy, activity-based hand therapy
- Keywords
- hand therapy, activity-based training, hand related injuries, sense of coherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint mobility exercises hand therapyOther
Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
activity-based hand therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Joint mobility exercises hand therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder, and Hand questionnaire
Measured: from baseline to 12 months after start of rehabilitation
Secondary outcomes (4)
The EQ-5D Quality of life questionnaire
Measured: From baseline to 3 months
Sense of Coherence Questionnaire
13 items questionnaire
Measured: From baseline to 12 months
Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
Measured: From baseline to 3 months
Satisfaction with daily living and rehabilitation
Measured: From baseline to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Related InjuriesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark, Bevica Fonden, Danish Association of Occupational Therapist
- Responsible party
- Principal investigator, Alice Ørts Hansen, Odense University Hospital
- Investigators
- Hans B Tromborg, Ph.D, Study chair, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098564
- Sponsor's protocol ID
- REHAB123
- Status last verified
- Aug 2018
- First submitted
- 21 Mar 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores
- ClinicalTrials.gov ID
- NCT02098564
- Acronym / sponsor ID
- REHAB123
- Conditions
- Hand Related Injuries
- Keywords
- hand therapy, activity-based training, hand related injuries, sense of coherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark, Bevica Fonden, Danish Association of Occupational Therapist
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| strong sense of coherence control group | Active comparator | Other: Joint mobility exercises hand therapyPatients 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. |
| strong sense of coherence intervention | Experimental | Other: activity-based hand therapyPatients 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. |
| weak sense of coherence control group | Active comparator | Other: Joint mobility exercises hand therapyPatients 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. |
| weak sense of coherence intervention | Experimental | Other: activity-based hand therapyPatients 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. |
| medium sense of coherence intervention | Experimental | Other: activity-based hand therapyPatients 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. |
| medium sense of coherence control group | Active comparator | Other: Joint mobility exercises hand therapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint mobility exercises hand therapyJoint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program | Other | medium sense of coherence control group, strong sense of coherence control group, weak sense of coherence control group |
| activity-based hand therapyintervention 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. | Other | medium sense of coherence intervention, strong sense of coherence intervention, weak sense of coherence intervention |
Primary outcome
Disabilities of the Arm, Shoulder, and Hand questionnaire
Time frame: from baseline to 12 months after start of rehabilitation
4 secondary outcomes
The EQ-5D Quality of life questionnaire
Time frame: From baseline to 3 months
Sense of Coherence Questionnaire
Time frame: From baseline to 12 months
Canadian Occupational Performance Measure (COPM) Canadian Occupational Performance Measure (COPM)
Time frame: From baseline to 3 months
Satisfaction with daily living and rehabilitation
Time frame: From baseline to12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans B Tromborg, Ph.D study chair
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint mobility exercises hand therapy and activity-based hand therapy in people with Hand Related Injuries, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder, and Hand questionnaire (time frame: from baseline to 12 months after start of rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.