Cross-education for Proximal Humerus Fracture Rehabilitation

NCT03017105 | Terminated Phase 1

• 1 other identifier: 5222
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Oxford Shoulder Score

  12 weeks after injury

Secondary Outcomes (2)

• EuroQoL-5D-5L

  at 6 weeks & 12 weeks after injury

• Oxford Shoulder Score

  at 6 weeks after injury

Study Arms (2)

Control

ACTIVE COMPARATOR

Usual rehabilitation: non-operative management of the fracture; will undergo usual physiotherapy rehabilitation for the injured arm

Other: Usual rehabilitation

Experimental

EXPERIMENTAL

Cross-education of strength-training: non-operative management of the fracture; will undergo usual physiotherapy rehabilitation for the injured arm but will also undergo strength-training for the uninjured arm

Other: Cross-education of strength-training; Other: Usual rehabilitation

Interventions

Cross-education of strength-training OTHER

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

Experimental

Usual rehabilitation OTHER

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

Control; Experimental

Eligibility Criteria

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

You may qualify if:

• Proximal humerus fracture \<2 weeks old
• Isolated injury sustained
• After low-energy trauma (i.e. simple fall from standing; high-energy injuries often have concurrent injuries or require surgery)
• For conservative management
• English speaking/understanding (for the duration of the pilot; the full study could be extended to include use of translated information and interpreters)
• Independent living at the time of injury (i.e. not institutionalised, so measure of function is a relevant outcome)

You may not qualify if:

• Concurrent injuries
• Fractured shaft of or distal humerus
• Pathological fracture (due to cancer) or fracture as a result of high energy trauma
• Previous fracture or pathology to either side
• History of upper extremity neurological problems (e.g. multiple sclerosis, stroke, Parkinson's disease, vestibular disorders, reflex neuropathy)
• Diagnosis of dementia/other cognitive impairment
• Not able to attend the Trust's outpatient departments for rehabilitation

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• Manchester Metropolitan University: collaborator

Related Publications (1)

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

  PMID: 35727196 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share