Is Sensorimotor Training Effective Following a Distal Radius Fracture?

NCT ID: NCT06299228

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Distal Radius Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

The experimental group will receive sensorimotor intervention and traditional hand therapy

Group Type EXPERIMENTAL

Experimental Group

Intervention Type OTHER

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

Control Group

Control Group will receive Hand Therapy only

Group Type EXPERIMENTAL

Control Group

Intervention Type OTHER

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

Interventions

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Experimental Group

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

Intervention Type OTHER

Control Group

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Touro University Nevada

OTHER

Sponsor Role collaborator

Orthopaedic Specialty Group PC, Fairfield

OTHER

Sponsor Role collaborator

Hand Surgery Associates LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hand Surgery Associates

Olyphant, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nancy Naughton, OTD

Role: CONTACT

5707808681

Kristen Valdes, OTD

Role: CONTACT

9414685500

Facility Contacts

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Nancy Naughton, OTD

Role: primary

570-780-8681

Lori Algar, OTD

Role: backup

2034514938

Other Identifiers

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HSA

Identifier Type: -

Identifier Source: org_study_id

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