Thumb and Wrist Proprioception Exercises to Improve Pain Sensibility and Manual Dexterity After Distal Radius Fracture.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Malaga
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Force sense (FS)
Study Overview
Brief Summary
Distal radius fracture is the most common upper extremity fracture with peak incidence among older women after the fifth decade of life. Proprioception is one constituent of a complex Sensory motor control process. Proprioception requires the reception and central integration of incoming afferent signals. Although various sensory and motor deficits have been correlated with significant functional impairment after wrist trauma, limited research exists on the effects of proprioception and multi sensory training after distal radius fracture.
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, for dexterity Due pegboard test will be used. 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control group
Wrist passive mobilizations; Actives exercises; Reeducation for Activity daily life;
Intervention: Thumb active Exercises (Other)
Experimental group
The experimental group will also carried out a proprioceptive exercise home program with a laptop.
Intervention: Thumb active Exercises (Other)
Outcomes
Primary Outcomes
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.
Joint position Sense (JPS)
Time Frame: baseline-3 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.
Secondary Outcomes
- PRWE Patient review wrist evaluation(baseline-3 months)
- Pain (VAS)(baseline-3 months)
- Canadian Occupational Performance Measure(baseline-3 months)
- Dexterity test. Purdue pegboard(baseline-3 months)
Investigators
Raquel Cantero-Téllez
PhD
University of Malaga