Well-arm Exercise in Distal Radius Fractures

NCT ID: NCT04089709

Last Updated: 2022-07-25

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

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-03-20

Brief Summary

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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

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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

Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Study arm

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

Group Type EXPERIMENTAL

Well-arm Exercise

Intervention Type BEHAVIORAL

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.

Control arm

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Well-arm Exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Trent Guthrie

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuart T Guthrie, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital System

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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11912

Identifier Type: -

Identifier Source: org_study_id

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