Is Sensorimotor Training Effective Following a Distal Radius Fracture?

Not Applicable

Recruiting

• Conditions: Distal Radius Fractures
• Interventions: Other: Experimental Group; Other: Control Group

• Registration Number: NCT06299228
• Lead Sponsor: Hand Surgery Associates LLC

Brief Summary

The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.

Detailed Description

The study is an interventional study investigating the effectiveness of sensorimotor activities in addition to traditional occupational therapy intervention versus traditional intervention only for patients following a distal radius fracture with volar plate fixation. A convenience sample of patients from 2 outpatient orthopedic hand therapy departments will be invited to participate in the study.

The treatment for both groups will be identical with one group receiving the addition of sensorimotor activities. Participants will be divided into one of the two groups. They will be made aware that at any point they can choose to no longer participate in the study, and it will not affect their treatment.

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-07
• Status Verified: 2024-04
• Study Start: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Distal radius fracture with volar plate fixation
• Understand English
• 18 years or older
• Available to attend skilled occupational therapy visits a minimum of 1x per week.

Exclusion Criteria

• Prior surgery to the involved wrist/hand
• Cognitive impairment
• Distal radius fracture managed by casting or by another means of fixation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Experimental Group	The experimental group will receive sensorimotor intervention and traditional hand therapy
Control Group	Control Group	Control Group will receive Hand Therapy only

Primary Outcome Measures

Name	Time	Method
Active Joint Position Sense (AJPS)	Baseline, 3 and 6 weeks	Range of motion measurement for the wrist, the measurements are recorded in degress of motion and the greater the number of degrees is reflective of greater sensorimotor deficit

Secondary Outcome Measures

Name	Time	Method
Patient Rated Wrist and Hand Evaluation	Baseline, 3 and 6 weeks	Patient reported outcome measurement with a 0-100 range, 0 indicating no functional deficit and 100 indicating the worst functional scale

Trial Locations

Locations (1)

Hand Surgery Associates; 🇺🇸 Olyphant, Pennsylvania, United States