Well-arm Exercise in Distal Radius Fractures

NCT04089709 | Terminated DMC

• 1 other identifier: 11912
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Distal Radius Fracture

Keywords

Distal radius fracture; cross-education; immobilization

Outcome Measures

Primary Outcomes (2)

• Grip strength

  Grip strength will be measured using a dynamometer at all clinic visits.

  3 months

• 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 Outcomes (1)

• Pain scores of injured arm.

  3 months

Other Outcomes (1)

• Wrist Range of Motion

  3 months

Study Arms (2)

Study arm

EXPERIMENTAL

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

Behavioral: Well-arm Exercise

Control arm

NO INTERVENTION

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.

Interventions

Well-arm Exercise 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.

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Stuart T Guthrie, MD

  Henry Ford Hospital System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 13, 2019
• Study Start: November 30, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)