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Cross-education for Proximal Humerus Fracture Rehabilitation

NCT03017105 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-01-06

No results posted yet for this study

Summary

Proximal humerus fractures (break of the top part of the upper arm bone) are common in older people with poorer bone quality. Often patients do not undergo surgery for these fractures: the bone fragments may be in an acceptable enough position to be able to heal naturally, or the patient may not be well enough medically to undergo an operation. These patients need to wear a sling to immobilise their injured shoulder, however muscles start to weaken quickly when they are unable to be used. This research project will look at whether strength-training the opposite/uninjured limb, known as "cross education", has any effect on preserving the function of the injured/fractured limb. Participants will be randomised into two groups using minimisation, that is to say the groups will have balanced numbers in terms of exact pattern of fracture and gender. One group will receive traditional rehabilitation exercises and treatment by the physiotherapist for their injured limb; the other group will receive the same but in addition will also undergo a strength-training exercise programme for their uninjured limb. Only qualified physiotherapists with experience of treating this patient cohort will be involved. Sessions in the physiotherapy department will last up to 30 minutes each and will comprise of: patient review, exercise progression, and advice giving/question answering; home exercise programmes will be expected to be completed 2-3 times daily and last up to 30 minutes each; number of sessions will be agreed between the participant and treating physiotherapist with treating ending once an agreed, acceptable level of function has been achieved. The Oxford Shoulder Score patient-reported outcome measure will be completed by the participant at 6 and 12 weeks and the European Quality of Life (EuroQoL)-5D-5L at 12 weeks after commencement of treatment.

Conditions

  • Proximal Humerus Fractures (to be Managed Non-operatively)

Interventions

OTHER

Cross-education of strength-training

Strength-training exercises using isometric contractions and resistance bands to be performed with the uninjured arm

OTHER

Usual rehabilitation

Exercises to improve range of movement, strength and movement control (as standard for non-operatively managed proximal humerus fractures)

Sponsors & Collaborators

  • Manchester Metropolitan University

    collaborator OTHER

  • Liverpool University Hospitals NHS Foundation Trust

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-11-30
Completion
2019-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03017105 on ClinicalTrials.gov