Proprioception and Multi Sensory Training After DRF

Distal Radius Fracture Clinical Trial

Official title:

The Role of Proprioception and Multi Sensory Training on Recovery and Patient Satisfaction After Distal Radius Fracture. Randomized Control Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04820114
• Other study ID #: Wrist 1 UMA
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2021
• Source: University of Malaga
• Contact: Raquel Cantero, PhD
• Phone: 0034 951952850
• Email: cantero[@]uma.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: January 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Wrist Fracture

Intervention

Other:
• Proprioceptive wrist exercises
Exercises for recognition of writs position and thumb force sense.
• Wrist exercises
Passive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation

Locations

Country	Name	City	State
Spain	Raquel Cantero-Téllez	Malaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint position Sense (JPS)	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
Primary	Force sense (FS)	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	Visual Analogue Scale (VAS)	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
Secondary	Canadian Occupational Performance Measure	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
Secondary	PRWE Patient review wrist evaluation	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