Is Sensorimotor Training Effective Following a Distal Radius Fracture?

Distal Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299228
• Other study ID #: HSA
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Hand Surgery Associates LLC
• Contact: Nancy Naughton, OTD
• Phone: 5707808681
• Email: nancynaughton10[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Experimental Group
Sensorimotor intervention, active range of motion, active assisted range of motion, strengthening
• Control Group
Active range of motion, active assisted range of motion and strengthening

Locations

Country	Name	City	State
United States	Hand Surgery Associates	Olyphant	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Hand Surgery Associates LLC	Orthopaedic Specialty Group PC, Fairfield, Touro University Nevada

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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