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
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fracture||Behavioral: Well-arm Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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.|
|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|
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.
- Grip strength [ Time Frame: 3 months ]Grip strength will be measured using a dynamometer at all clinic visits.
- 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.
- 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.
- Wrist Range of Motion [ Time Frame: 3 months ]Range of motion of the injured wrist will be measured after the period of immobilization.
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
|Contact: Stuart T Guthrie, MDemail@example.com|
|Contact: Lindsay M Maier, MDfirstname.lastname@example.org|
|United States, Michigan|
|Henry Ford Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Stuart T Guthrie, MD||Henry Ford Hospital System|