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Well-arm Exercise in Distal Radius Fractures

Primary Purpose

Distal Radius Fracture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Well-arm Exercise
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal radius fracture, cross-education, immobilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults >18 years with an isolated distal radius fracture treated non-operatively

Exclusion Criteria:

  • Operative treatment, additional injures, previous injury to same arm, neuropathy or neuromuscular disease, dementia

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study arm

Control arm

Arm Description

Patients randomized to this group will be provided exercises to perform with the uninjured arm once daily for 3 months.

Patients randomized to this group will not be provided exercises for the "well-arm" and will be managed according to the current standard of care.

Outcomes

Primary Outcome Measures

Grip strength
Grip strength will be measured using a dynamometer at all clinic visits.
Forearm Circumference
Forearm circumference will be measured at the widest point of the forearm, approximately 2cm distal to the elbow. This measurement will be taken at all clinic visits.

Secondary Outcome Measures

Pain scores of injured arm.
A visual analog scale (VAS) score will be collected at the first and all subsequent clinic visits.

Full Information

First Posted
September 12, 2019
Last Updated
July 20, 2022
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04089709
Brief Title
Well-arm Exercise in Distal Radius Fractures
Official Title
Well-arm Exercise in Distal Radius Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Covid-19
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A single center randomized control study. Patients >18 years with isolated distal radius fractures treated non-operatively will be randomly assigned to either the treatment group (exercise of contralateral "well" arm) or control group (standard fracture care and rehabilitation).
Detailed Description
Distal radius fractures are common injuries, especially in the aging population. Fracture healing requires immobilization of the injury, which inevitably leads to muscle atrophy and joint stiffness. This strength lost during immobilization can be problematic in patients who are already de-conditioned at baseline. Previous research using healthy participants found that exercising a non-immobilized, "well", arm helped attenuate muscle atrophy in the contralateral immobilized arm. The study aims to answer the following questions: Does exercise of the contralateral arm prevent muscle atrophy and weakness of the injured arm? Does exercise of the contralateral arm improve pain scores in the injured arm

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Distal radius fracture, cross-education, immobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
Masking
Outcomes Assessor
Masking Description
Patients will be randomized using an online randomization tool. Study folders will be placed in order and include the consent form and exercise sheet if randomized to the treatment group. Those randomized to the control group will be given an information sheet on distal radius fractures. Patients will be consented by an unblinded research assistant in order for the treating physician to remain blinded.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm Description
Patients randomized to this group will be provided exercises to perform with the uninjured arm once daily for 3 months.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patients randomized to this group will not be provided exercises for the "well-arm" and will be managed according to the current standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Well-arm Exercise
Intervention Description
Patients randomized to the treatment arm will perform these exercises on the contralateral arm once daily for 3 months: wrist flexion and extension, ball or sock squeeze, wrist curls and biceps curls. Participants allocated to this study arm will be provided a print out of the exercises with detailed explanations and pictures of each exercise.
Primary Outcome Measure Information:
Title
Grip strength
Description
Grip strength will be measured using a dynamometer at all clinic visits.
Time Frame
3 months
Title
Forearm Circumference
Description
Forearm circumference will be measured at the widest point of the forearm, approximately 2cm distal to the elbow. This measurement will be taken at all clinic visits.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain scores of injured arm.
Description
A visual analog scale (VAS) score will be collected at the first and all subsequent clinic visits.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Wrist Range of Motion
Description
Range of motion of the injured wrist will be measured after the period of immobilization.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults >18 years with an isolated distal radius fracture treated non-operatively Exclusion Criteria: Operative treatment, additional injures, previous injury to same arm, neuropathy or neuromuscular disease, dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart T Guthrie, MD
Organizational Affiliation
Henry Ford Hospital System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

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Well-arm Exercise in Distal Radius Fractures

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