Clinical trial NCT04820114: Proprioception and Multi Sensory Training After DRF
Official title: The Role of Proprioception and Multi Sensory Training on Recovery and Patient Satisfaction After Distal Radius Fracture. Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Wrist Fracture
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Joint position Sense (JPS)
timeFrame: Baseline-6 months
measure: Force sense (FS)
timeFrame: Baseline- 3 months
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline-3 months
measure: Canadian Occupational Performance Measure
timeFrame: Baseline-3 months
measure: PRWE Patient review wrist evaluation
timeFrame: Baseline-3 months
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Raquel Cantero-Téllez
state: Málaga
Study officials:
References: