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Cross-education for Proximal Humerus Fracture Rehabilitation

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ClinicalTrials.gov Identifier: NCT03017105
Recruitment Status : Terminated (Logistical difficulties leading to an extremely slow recruitment rate)
First Posted : January 11, 2017
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
Manchester Metropolitan University
Information provided by (Responsible Party):
Jenna Bardsley, Liverpool University Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Proximal Humerus Fractures (to be Managed Non-operatively) Other: Cross-education of strength-training Other: Usual rehabilitation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Comparing the Use of Cross-education of Strength-training for the Non-injured Limb With Traditional Rehabilitation After Conservatively Managed Proximal Humerus Fractures in Adult Patients
Study Start Date : January 2017
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019


Arm Intervention/treatment
Active Comparator: Control
Usual rehabilitation: non-operative management of the fracture; will undergo usual physiotherapy rehabilitation for the injured arm
Other: Usual rehabilitation
Exercises to improve range of movement, strength and movement control (as standard for non-operatively managed proximal humerus fractures)

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
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)




Primary Outcome Measures :
  1. Oxford Shoulder Score [ Time Frame: 12 weeks after injury ]

Secondary Outcome Measures :
  1. EuroQoL-5D-5L [ Time Frame: at 6 weeks & 12 weeks after injury ]
  2. Oxford Shoulder Score [ Time Frame: at 6 weeks after injury ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
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Responsible Party: Jenna Bardsley, Principle Investigator, Liverpool University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03017105    
Other Study ID Numbers: 5222
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries