Thumb and Wrist Proprioception Exercises.

NCT ID: NCT04930718

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2021-09-20

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.

Conditions

Radius Fractures; Hand Injuries; Pain, Chronic; Proprioceptive Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control group

Wrist passive mobilizations; Actives exercises; Reeducation for Activity daily life;

Group Type: ACTIVE_COMPARATOR

Thumb active Exercises

Intervention Type: OTHER

Active específico exercises; Reeducation program

Experimental group

The experimental group will also carried out a proprioceptive exercise home program with a laptop.

Group Type: EXPERIMENTAL

Thumb active Exercises

Intervention Type: OTHER

Active específico exercises; Reeducation program

Interventions

Thumb active Exercises

Active específico exercises; Reeducation program

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Raquel Cantero-Téllez

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Raquel Cantero-Téllez

Málaga, Málaga, Spain

Countries

Spain

Other Identifiers

UMA-Proprioception

Identifier Type: -

Identifier Source: org_study_id