- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04820114
Proprioception and Multi Sensory Training After DRF
The Role of Proprioception and Multi Sensory Training on Recovery and Patient Satisfaction After Distal Radius Fracture. Randomized Control Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients diagnosis of distal radius fracture (aged 18 years and above). Both assessor and statistician will remained blinded.
Standard rehabilitation program for distal radius fracture treatments will received for both the control and experimental groups for a period of 12 weeks. The experimental group, in addition, will received a proprioceptive training program during the same intervention period, which will be conducted twice weekly (24 sessions).
The severity of pain with activity will be measured according to the visual analog scale (VAS). PRWE questionnaire will be used to measure upper extremity function. Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) and proprioception with Joint position sense (JPS) and force sense (FS) testing. All outcome measures will be collected at baseline, immediately following the intervention at 3 weeks and at 12 weeks following the end of the intervention.
Participation in the study will be voluntary and patients will be included if they satisfied specific inclusion criteria.
All procedures will be follow in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. All participants will sign a written informed consent in accordance with guidelines approved by the local ethics committee.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raquel Cantero, PhD
- Phone Number: 0034 951952850
- Email: cantero@uma.es
Study Locations
-
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Málaga
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Malaga, Málaga, Spain, 29012
- Recruiting
- Raquel Cantero-Téllez
-
Contact:
- Raquel Cantero-Téllez
- Phone Number: +34606267101
- Email: cantero@uma.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient diagnosis of distal radius fracture.
- Wrist immobilization after lesion (unless 3 weeks)
- Capacity for sing inform concept and understand the exercises
Exclusion Criteria:
- Others associate fractures in hand or upper limb
- Wrist ligaments injuries
- Neurological disorder affecting the upper limb
- Have received previous proprioceptive training for upper limb injury.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
The experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase.
|
Passive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation
Exercises for recognition of writs position and thumb force sense.
|
Active Comparator: Control group
Wrist passive mobilizations; Actives exercises; Reeducation for Activity daily life.
|
Passive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Joint position Sense (JPS)
Time Frame: Baseline-6 months
|
Proprioception using active joint position sense (JPS) has been utilized in studies to establish a correlation between therapy intervention and proprioception.
Joint angle will be measured using a standard clear plastic goniometer.
|
Baseline-6 months
|
Force sense (FS)
Time Frame: Baseline- 3 months
|
Muscle strength (MS) is one of the most important factors affecting human performance.
Force sense (FS) is also known as sense of effort / heaviness / tension or the force matching sense.
It is the ability to reproduce (or match) a desired level of force one or more times.
|
Baseline- 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: Baseline-3 months
|
VAS has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes.
It consists of a 10-cm line anchored at each end.
The left-hand anchor reads 'no pain' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level.
|
Baseline-3 months
|
Canadian Occupational Performance Measure
Time Frame: Baseline-3 months
|
Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM).
The COPM enables subjects to identify goals for hand therapy and engage in a subject-specific therapeutic process.
|
Baseline-3 months
|
PRWE Patient review wrist evaluation
Time Frame: Baseline-3 months
|
PRWE is the Patient-Rated Wrist Evaluation, It is one of the reliable upper extremity outcome instrument.The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.
Developed in 1998 for clinical assessment and is used for specific wrist problems.
|
Baseline-3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wrist 1 UMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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