Is Sensorimotor Training Effective Following a Distal Radius Fracture?

Sensorimotor Training and Hand Therapy Versus Traditional Hand Therapy Alone Following a Distal Radius Fracture With Volar Plate Fixation: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Distal Radius Fractures
• Intervention / Treatment: Other: Experimental Group; Other: Control Group

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The experimental group will receive sensorimotor intervention and traditional hand therapy	Other: Experimental Group; Sensorimotor intervention, active range of motion, active assisted range of motion, strengthening
Experimental: Control Group; Control Group will receive Hand Therapy only	Other: Control Group; Active range of motion, active assisted range of motion and strengthening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Joint Position Sense (AJPS)	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	Baseline, 3 and 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hand Surgery Associates LLC
• Collaborators: Orthopaedic Specialty Group PC, Fairfield; Touro University Nevada

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Fractures, Bone; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: HSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the researchers identified will have access to the participant data. 2 of the 3 researchers identified will be collecting the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No