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Well-arm Exercise in Distal Radius Fractures

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ClinicalTrials.gov Identifier: NCT04089709
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Trent Guthrie, Henry Ford Health System

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).

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Behavioral: Well-arm Exercise Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
Official Title: Well-arm Exercise in Distal Radius Fractures
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study arm
Patients randomized to this group will be provided exercises to perform with the uninjured arm once daily for 3 months.
Behavioral: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Grip strength [ Time Frame: 3 months ]
    Grip strength will be measured using a dynamometer at all clinic visits.

  2. Forearm Circumference [ Time Frame: 3 months ]
    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 :
  1. Pain scores of injured arm. [ Time Frame: 3 months ]
    A visual analog scale (VAS) score will be collected at the first and all subsequent clinic visits.


Other Outcome Measures:
  1. Wrist Range of Motion [ Time Frame: 3 months ]
    Range of motion of the injured wrist will be measured after the period of immobilization.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089709


Contacts
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Contact: Stuart T Guthrie, MD 313-916-2181 tguthri1@hfhs.org
Contact: Lindsay M Maier, MD 313-932-0845 lmaier1@hfhs.org

Locations
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United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Stuart T Guthrie, MD Henry Ford Hospital System

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Responsible Party: Trent Guthrie, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT04089709     History of Changes
Other Study ID Numbers: 11912
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Trent Guthrie, Henry Ford Health System:
Distal radius fracture
cross-education
immobilization
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries