NCT06562218

Brief Summary

The cross-training phenomenon is the increase in muscle strength in the contralateral limb when one limb is exercised. Limited studies have shown that it prevents immobilisation-induced muscle weakness in healthy volunteers. The aim of this study was to evaluate the effect of strengthening the contralateral extremity on muscle strength and range of motion in the immobilised extremity in patients who had undergone immobilisation for forearm fractures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

August 26, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

June 26, 2025

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

August 16, 2024

Last Update Submit

June 25, 2025

Conditions

Keywords

fractureimmobilisationcross-educationmuscle strength

Outcome Measures

Primary Outcomes (2)

  • Wrist isometric flexion muscle strength

    The isometric flexion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased.

    1 year

  • Wrist isometric extansion muscle strength

    The isometric extansion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased.

    1 year

Study Arms (2)

cross training group

EXPERIMENTAL

Group whose healthy arm (unbroken side) is strengthened

Procedure: isokinetic strengthening exercise

control group

EXPERIMENTAL

group given conventional exercise to the fractured arm

Procedure: conventional exercise programm

Interventions

Participants' isokinetic strength measurements will be assessed using the Cybex II Humac Norm isokinetic dynamometer. A strengthening programme will be performed for a total of 12 sessions, 3 days a week for 4 weeks, at 20 degrees of flexion, 20 degrees of extension, 60-90 and 180 degrees/s speed. At the beginning and end of the 12th session, isokinetic and isometric muscle performance tests will be performed on the healthy wrist, and isometric wrist flexor and extensor strength measurements will be performed in neutral position 1 week after removal of the cast on the fractured wrist.

cross training group

The immobilised limb was given finger grip exercises.

control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic unilateral forearm fracture (treated surgically or conservatively and immobilised in a cast)

You may not qualify if:

  • Previous upper limb surgery/joint disease - deformity affecting hand-wrist function
  • Any neurological condition affecting the upper extremity (stroke, Parkinson's disease; multiple sclerosis, reflex sympathetic dystrophy, peripheral nerve injury)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not know which group they have been assigned to, and the researchers evaluating the results will not know which group participants have been assigned to.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: prospective randomized controlled double-blind clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 20, 2024

Study Start

August 26, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

June 26, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations