Well-arm Exercise in Distal Radius Fractures

Distal Radius Fracture Clinical Trial

Official title:

Well-arm Exercise in Distal Radius Fractures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04089709
• Other study ID #: 11912
• Status: Terminated
• Phase: N/A
• Start date: November 30, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: July 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wrist Range of Motion	Range of motion of the injured wrist will be measured after the period of immobilization.	3 months
Primary	Grip strength	Grip strength will be measured using a dynamometer at all clinic visits.	3 months
Primary	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.	3 months
Secondary	Pain scores of injured arm.	A visual analog scale (VAS) score will be collected at the first and all subsequent clinic visits.	3 months