Distal Radius FracturePhase 2/3NCT02838446
Effectiveness of Graded Motor Imagery to Improve Hand Function in Patients With Distal Radius Fracture
A Phase 2/3 study testing Cognitive Therapy in people with Distal Radius Fracture and Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was carried out on 36 patients. These patients were randomly assigned to two groups: classic treatment group (n=19) and GMI group (n=17). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture, Pain
- What is being tested?
- Cognitive Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jun 2015
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages between 18-65 years
- diagnosed with DRFx which is extra-articular
- managed with pins, internal fixation and/or cast
Who cannot join
- unwilling or unable to participate
- intra-articular and instable fractures containing other part of the fractures
- fractures related with the malignancy and other neurologic diseases
- existing inflammatory joint condition,
- lack of cognitive function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Therapy Model: Graded Motor Imagery
The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was carried out on 36 patients. These patients were randomly assigned to two groups: classic treatment group (n=19) and GMI group (n=17). Both groups received a 8-week (2 days a week) physical therapy and rehabilitation intervention. Outcome measurements were based on upper extremity functional status (Disability of the Arm Shoulder Hand and Michigan Hand Questionnaire scores), pain (on the rest and during the activity with Visual Analog Scale), range of motion (wrist flexion, extension, ulnar/radial deviation, supination and pronation with goniometer), grip strength (standard grip strength with Jamar hydraulic hand dynamometer; lateral, palmar and pinch strength with pinch meter).
- Conditions
- Distal Radius Fracture, Pain
- Being tested
- Cognitive Therapy
- Medical subject headings
- Wrist Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TherapyProcedure or surgery
Also called Rehabilitation
Graded Motor Imagery has three stages:
Lateralisation (2 or 3 weeks) Motor Imagery (2 or 3 weeks) Mirror Therapy (2 or 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy | Experimental | Graded motor imagery program was applied in only intervention group for 8 weeks. Receives: Procedure: Cognitive Therapy |
| Control | Active comparator | Rehabilitation program applied in both groups for 8 weeks. Frequency of the treatment was 2 days in per week and its duration was approximately one hour in one session. Receives: Procedure: Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function and Symptoms
Disability of the Arm, Shoulder and Hand (DASH) questionnaire scores range from 0 to 100 with a higher score indicating higher degree of disability.
Measured: 8 weeks
Secondary outcomes (3)
Pain intensity
Visual Analog Scale (VAS) is used to evaluate pain intensity. The scale was consisted of a standard line labeled 0 on the left and 10 on the right. (0: no pain, 10: the worst pain).
Measured: 8 weeks
Normal range of motion
Active range of motions of wrist regarding flexion, extension, ulnar deviation, radial deviation, supination and pronation were evaluated with universal goniometer and recorded as degree.
Measured: 8 weeks
Grip Strength
Grip strength was measured in kilograms using a calibrated Jamar Hydraulic Hand Dynamometer with the elbow flexed to 90 degree.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Burcu Dilek, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838446
- Sponsor's protocol ID
- GO 14/06
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Therapy Model: Graded Motor Imagery
- ClinicalTrials.gov ID
- NCT02838446
- Acronym / sponsor ID
- GO 14/06
- Conditions
- Distal Radius Fracture, Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Jul 2016 (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.
The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was carried out on 36 patients. These patients were randomly assigned to two groups: classic treatment group (n=19) and GMI group (n=17). Both groups received a 8-week (2 days a week) physical therapy and rehabilitation intervention. Outcome measurements were based on upper extremity functional status (Disability of the Arm Shoulder Hand and Michigan Hand Questionnaire scores), pain (on the rest and during the activity with Visual Analog Scale), range of motion (wrist flexion, extension, ulnar/radial deviation, supination and pronation with goniometer), grip strength (standard grip strength with Jamar hydraulic hand dynamometer; lateral, palmar and pinch strength with pinch meter).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy | Experimental | Procedure: Cognitive TherapyGraded motor imagery program was applied in only intervention group for 8 weeks. |
| Control | Active comparator | Procedure: Cognitive TherapyRehabilitation program applied in both groups for 8 weeks. Frequency of the treatment was 2 days in per week and its duration was approximately one hour in one session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages between 18-65 years
- diagnosed with DRFx which is extra-articular
- managed with pins, internal fixation and/or cast
Key exclusion criteria (5 listed)
- unwilling or unable to participate
- intra-articular and instable fractures containing other part of the fractures
- fractures related with the malignancy and other neurologic diseases
- existing inflammatory joint condition,
- lack of cognitive function.
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 |
|---|---|---|
| Cognitive TherapyAlso: RehabilitationGraded Motor Imagery has three stages: Lateralisation (2 or 3 weeks) Motor Imagery (2 or 3 weeks) Mirror Therapy (2 or 3 weeks) | Procedure or surgery | Cognitive Therapy, Control |
Primary outcome
Physical Function and Symptoms
Time frame: 8 weeks
Disability of the Arm, Shoulder and Hand (DASH) questionnaire scores range from 0 to 100 with a higher score indicating higher degree of disability.
3 secondary outcomes
Pain intensity
Time frame: 8 weeks
Normal range of motion
Time frame: 8 weeks
Grip Strength
Time frame: 8 weeks
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 20 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive Therapy in people with Distal Radius Fracture and Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 20 Jul 2016. 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 Turkey (Türkiye). 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical Function and Symptoms (time frame: 8 weeks). 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 20 Jul 2016.