Physical DisabilityNCT04071002
Patients With Distal Radius Fracture
A study testing 12 weeks physical therapy programme in people with Physical Disability, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Surgically and conservatively treated distal radius fractures followed for six month. In this period 12 weeks rehabilitation programme applied for each group. Nine different evaluations were done in the initial, after physical therapy and 6th month. Results were presented. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Physical Disability
- What is being tested?
- 12 weeks physical therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2015to 1 Sep 2016
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 60
- Diagnosed with distal radius fracture
- Primary fixation after injury.
Who cannot join
- Bilateral distal radius fracture
- Concomitant ulna styloid fracture
- Another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb
- Patients who underwent surgery that involved ipsilateral upper extremity
- Associated injuries such as nerve or tendon injuries
- Secondary procedures at follow-up
- Un-cooperated patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Status and Activity Participation Levels in Patients With Distal Radius Fracture
Surgically and conservatively treated distal radius fractures followed for six month. In this period 12 weeks rehabilitation programme applied for each group. Nine different evaluations were done in the initial, after physical therapy and 6th month. Results were presented.
Read the detailed description
Distal radius fracture (DRF) affects overall health status. The International Classification of Function (ICF) based approach is appropriate in the management of DRF. The purpose of this study was to investigate functional status and activity participation levels of DRF patients.
The patients were divided into conservative and surgical groups and were admitted to 12-weeks rehabilitation period. The evaluation of the body function and structure were done with Visual Analogue Scale, algometer, range of motion (ROM) and grip strength. Also, radiographic evaluations were done. Activity participation assessments were done with Push-Off Test (POT), Michigan Hand Outcomes Questionnaire (MHOQ), Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH) and Jebsen-Taylor Hand Function Test (JTHFT). Mann-Whitney U and Wilcoxon Tests were used respectively for intergroup and intra-group comparisons. Statistical significance level was p<0,05.
- Conditions
- Physical Disability
- Being tested
- 12 weeks physical therapy programme
- Keywords
- Distal radius fracture, functional status, activity participation, hand therapy
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 weeks physical therapy programmeOther
The programme include contrast bath, bandage, massage, active exercises, resistive exercises.
| Study group | Role | What they receive |
|---|---|---|
| surgical group | Active comparator | distal radius fractures that treated volar plate Receives: Other: 12 weeks physical therapy programme |
| conservative group | Active comparator | distal radius fractures that treated plaster of paris Receives: Other: 12 weeks physical therapy programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
To evaluate pain severity, patient show a point to indicate her/his pain between 0-10 points on a vertical 100mm line. Severity of pain was assessed with VAS in sleep, rest, and activity.
Measured: six month
algometer
An algometer is used to evaluate pain threshold of the patient for distal radioulnar joint, ulnas styloid, m.pronator quadratus, radial styloid, m. flexor pollicis longus, and triangular fibrocartilage complex.The threshold value of pain was recorded by placing the probe against the points. Then, it was gradually increased and reduced to apply a pressure of 1kg / 0.5cm² with 0.5 cm² probe head .
Measured: six month
range of motion
An universal goniometer is used to evaluate patient's active motion of joints for wrist and forearm.
Measured: six month
grip strength
Grip strength was measured by a hand dynamometer according to the American Association of Hand Therapy Association's standard grip strength measurement method. Right/left extremity and their progression are compared in this evaluation.
Measured: six month
radiographic evaluations
The posteroanterior (PA) and lateral (L) radiographic measurements were assessed by an experienced hand surgeon to determine the type of fracture, geometry, and associated pathology. Radial length and radial inclination were assessed by PA radiography. Dorsal or volar angulations of the distal fragment were evaluated on the lateral radiography.
Measured: six month
Push-Off Test (POT)
POT was performed to determine the weight transfer strength of the patient to the injured extremity. The test was performed simultaneously and bilaterally by reversing the hand parts of the two hand dynamometers.
Measured: six month
Michigan Hand Outcomes Questionnaire (MHOQ)
MHOQ was used for evaluating the participation and functional levels of the patients. In the questionnaire consisting of 37 questions under six headings, general hand function, daily life activities, pain, work, aesthetics and satisfaction are evaluated. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.
Measured: six month
Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH)
It was used to assess the upper extremity functional status of patients from their perspective. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. It includes 11 item. The score on test ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity.
Measured: six month
Jebsen-Taylor Hand Function Test (JTHFT)
The seven individual subtests of JTHFT writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects, were performed as a standardized procedure.
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start21 Jan 2015
- Primary completion9 Jun 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE USTA, Pamukkale University
- Investigators
- HANDE USTA, MSC, Principal investigator, Pamukkale UniversityALI KITIS, PROF, Study chair, Pamukkale UniversityAHMET FAHIR DEMIRKAN, PROF, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071002
- Sponsor's protocol ID
- 3518
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valdes K, Naughton N, Michlovitz S. Therapist supervised clinic-based therapy versus instruction in a home program following distal radius fracture: a systematic review. J Hand Ther. 2014 Jul-Sep;27(3):165-73; quiz 174. doi: 10.1016/j.jht.2013.12.010. Epub 2014 Jan 3.
PubMed 24508093
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Status and Activity Participation Levels in Patients With Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT04071002
- Acronym / sponsor ID
- 3518
- Conditions
- Physical Disability
- Keywords
- Distal radius fracture, functional status, activity participation, hand therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 9 Jun 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 28 Aug 2019 (actual)
- 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.
Surgically and conservatively treated distal radius fractures followed for six month. In this period 12 weeks rehabilitation programme applied for each group. Nine different evaluations were done in the initial, after physical therapy and 6th month. Results were presented.
Detailed description
Distal radius fracture (DRF) affects overall health status. The International Classification of Function (ICF) based approach is appropriate in the management of DRF. The purpose of this study was to investigate functional status and activity participation levels of DRF patients.
The patients were divided into conservative and surgical groups and were admitted to 12-weeks rehabilitation period. The evaluation of the body function and structure were done with Visual Analogue Scale, algometer, range of motion (ROM) and grip strength. Also, radiographic evaluations were done. Activity participation assessments were done with Push-Off Test (POT), Michigan Hand Outcomes Questionnaire (MHOQ), Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH) and Jebsen-Taylor Hand Function Test (JTHFT). Mann-Whitney U and Wilcoxon Tests were used respectively for intergroup and intra-group comparisons. Statistical significance level was p<0,05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical group | Active comparator | Other: 12 weeks physical therapy programmedistal radius fractures that treated volar plate |
| conservative group | Active comparator | Other: 12 weeks physical therapy programmedistal radius fractures that treated plaster of paris |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18 and 60
- Diagnosed with distal radius fracture
- Primary fixation after injury.
Key exclusion criteria (7 listed)
- Bilateral distal radius fracture
- Concomitant ulna styloid fracture
- Another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb
- Patients who underwent surgery that involved ipsilateral upper extremity
- Associated injuries such as nerve or tendon injuries
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 |
|---|---|---|
| 12 weeks physical therapy programmeThe programme include contrast bath, bandage, massage, active exercises, resistive exercises. | Other | conservative group, surgical group |
Primary outcome
Visual Analogue Scale
Time frame: six month
To evaluate pain severity, patient show a point to indicate her/his pain between 0-10 points on a vertical 100mm line. Severity of pain was assessed with VAS in sleep, rest, and activity.
algometer
Time frame: six month
An algometer is used to evaluate pain threshold of the patient for distal radioulnar joint, ulnas styloid, m.pronator quadratus, radial styloid, m. flexor pollicis longus, and triangular fibrocartilage complex.The threshold value of pain was recorded by placing the probe against the points. Then, it was gradually increased and reduced to apply a pressure of 1kg / 0.5cm² with 0.5 cm² probe head .
range of motion
Time frame: six month
An universal goniometer is used to evaluate patient's active motion of joints for wrist and forearm.
grip strength
Time frame: six month
Grip strength was measured by a hand dynamometer according to the American Association of Hand Therapy Association's standard grip strength measurement method. Right/left extremity and their progression are compared in this evaluation.
radiographic evaluations
Time frame: six month
The posteroanterior (PA) and lateral (L) radiographic measurements were assessed by an experienced hand surgeon to determine the type of fracture, geometry, and associated pathology. Radial length and radial inclination were assessed by PA radiography. Dorsal or volar angulations of the distal fragment were evaluated on the lateral radiography.
Push-Off Test (POT)
Time frame: six month
POT was performed to determine the weight transfer strength of the patient to the injured extremity. The test was performed simultaneously and bilaterally by reversing the hand parts of the two hand dynamometers.
Michigan Hand Outcomes Questionnaire (MHOQ)
Time frame: six month
MHOQ was used for evaluating the participation and functional levels of the patients. In the questionnaire consisting of 37 questions under six headings, general hand function, daily life activities, pain, work, aesthetics and satisfaction are evaluated. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.
Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH)
Time frame: six month
It was used to assess the upper extremity functional status of patients from their perspective. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. It includes 11 item. The score on test ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity.
Jebsen-Taylor Hand Function Test (JTHFT)
Time frame: six month
The seven individual subtests of JTHFT writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects, were performed as a standardized procedure.
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 28 Aug 2019.
- Background: PubMed 24508093Valdes K, Naughton N, Michlovitz S. Therapist supervised clinic-based therapy versus instruction in a home program following distal radius fracture: a systematic review. J Hand Ther. 2014 Jul-Sep;27(3):165-73; quiz 174. doi: 10.1016/j.jht.2013.12.010. Epub 2014 Jan 3.
- Individual participant dataSharing planned: No
Related trials for Physical Disability
Not yet recruiting
Examining the Health Impact of and Promoting Sitting Light Volleyball in the Greater Bay Area
Physial Disabilities
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Recruiting
The STRIVE Before Surgery Trial
Surgery-Complications, Disability Physical
Active, not recruitingObservational study
Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients
Multiple Sclerosis
Not yet recruitingObservational study
A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.
Scleroderma
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.
HANDE USTA, MSC principal investigator
Pamukkale University
ALI KITIS, PROF study chair
Pamukkale University
AHMET FAHIR DEMIRKAN, PROF study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 weeks physical therapy programme in people with Physical Disability, run by Pamukkale 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 7 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 28 Aug 2019. 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.
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?
Visual Analogue Scale (time frame: six month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04071002, which also lists 1 linked publication.
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 28 Aug 2019.