Is Sensorimotor Training Effective Following a Distal Radius Fracture?

NCT06299228 | Recruiting

• 1 other identifier: HSA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Rated Wrist and Hand Evaluation

  Baseline, 3 and 6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will receive sensorimotor intervention and traditional hand therapy

Other: Experimental Group

Control Group

EXPERIMENTAL

Control Group will receive Hand Therapy only

Other: Control Group

Interventions

Experimental Group OTHER

Sensorimotor intervention, active range of motion, active assisted range of motion, strengthening

Experimental Group

Control Group OTHER

Active range of motion, active assisted range of motion and strengthening

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hand Surgery Associates LLC: lead
• Touro University Nevada: collaborator
• Orthopaedic Specialty Group PC, Fairfield: collaborator

Study Sites (1)

Hand Surgery Associates

Olyphant, Pennsylvania, 18447, United States

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Nancy Naughton, OTD

CONTACT

5707808681; nancynaughton10@gmail.com

Kristen Valdes, OTD

CONTACT

9414685500; kvaldes2@turo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)