None listed
Conditions
Brief summary
Background: Patients with musculoskeletal trauma, who receive treatment, care and support following discharge from hospital, are likely to have improved functionality and health outcomes. Early rehabilitation also results in reducing treatment costs, reduced disability and improved health related quality of life of these patients. Little is known about the efficacy of home-based rehabilitation programs particularly in resource poor setting where formal rehabilitation programs may be out of reach for many patients. Objectives: In the current multi-centre, randomised control trial, we aim to test the effectiveness of home-based physiotherapy rehabilitation program on functional outcomes and health related quality of life in patients with isolated traumatic fracture of the lower limb. Methods: Sample and sample size: Trauma patients aged 18 years and above, with isolated lower limb fractures requiring hospitalisation will be recruited in the study from three Indian trauma centres of Delhi, Mumbai, and Ahmedabad. A total of 382 patients will be recruited. Equal number of participants (n=191) will be allocated to the intervention group and control group using a computerized randomisation algorithm. Intervention: Physiotherapy rehabilitation program that will commence in the hospital and then continued as an individualised patient program at home for 24 weeks post definitive treatment or surgery. The exercise program will be prescribed by the orthopaedic surgeon in consultation with the hospital physiotherapist. Participant and their family will be trained by the hospital team before discharge. The treating physiotherapist will call the patient weekly for two weeks following discharge, then at least every fortnight until 24-weeks post definitive treatment or surgery to recommend further set of exercises. Each participant in the intervention group will receive voice messages once a week to their mobile phone, reminding them to complete the prescribed exercises. Control: Usual care at the time of hospitalisation and post-hospital care. Patients in both groups will attend the outpatient clinic for assessment if required for clinical care as per usual practice. Assessments: Participants will undergo a baseline interview during the hospitalisation period and follow up assessments at 6, 12 & 24 weeks post definitive treatment or surgery. All the assessment will be conducted by an independent assessor who will be blind to the intervention or control group. At the end of the intervention, key informant interviews will be conducted with health professionals, selected groups of patients and their family members, and other research team members. Outcomes: Primary outcomes will be the functional outcomes and health related quality of life at 24 weeks post definitive treatment or surgery will be the primary outcomes. Secondary outcomes will be the return to work and completion of prescribed exercises at 24 weeks.
Interventions
The intervention is a physiotherapy rehabilitation program commenced in the hospital then continued as an individualised patient program at home for 24 weeks post definitive treatment or surgery.
Patients will begin the intervention during the hospitalisation period with the physiotherapist and/or family members, with a focus on mobilisation prior to discharge.
Participants and their families will receive training on the exercises before discharge, along with an exercise manual (paper-based) w
The intervention is a physiotherapy rehabilitation program commenced in the hospital then continued as an individualised patient program at home for 24 weeks post definitive treatment or surgery. Patients will begin the intervention during the hospitalisation period with the physiotherapist and/or family members, with a focus on mobilisation prior to discharge. Participants and their families will receive training on the exercises before discharge, along with an exercise manual (paper-based) with tailored information related to the set and frequency of exercises. Exercises will be completed daily, but type and number of sets will be personalised by the physiotherapist based on participant's physical function and injury. The treating physiotherapist will call the patient weekly for two weeks following discharge, then at least every fortnight until 24-weeks post definitive treatment or surgery (unless face to face appointments are made) in order to recommend further set of exercises. Each participant in the intervention group will receive voice messages once a week to their mobile phone, reminding them to complete the prescribed exercises. Patients will attend the outpatient clinic for assessment if the physiotherapist or treating orthopaedic surgeon requires this for clinical care as per usual practice. Adherence: Participants will be asked about exercise completion at follow-up interviews.
Sponsors
Rebecca Ivers
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Patient age 18 years or older and alert to time, place & person 2.Isolated long bone fracture of the lower limb, i.e. femur and tibia, including any patients with an associated fracture of the same limb (unilateral) requiring non-operative fixation 3.The injury must be an acute injury; time from injury to hospital admission 14 days or less and patient hospitalised for at least 24 hours 4.Access to mobile telephone for 8 months from the day of hospital admission 5.The patient is available for follow-up telephone interviews at 6,12, and 24 weeks following surgery or definitive treatment.
Exclusion criteria
1. Open fractures requiring plastic surgery intervention or Grade-II/III (Gustilo) 2. Cognitive deficiency that in the opinion of the enrolling clinician, will affect the patient’s ability to follow study procedures 3. Injury to another body region likely to affect mobility, such as in case of polytrauma 4. A terminal illness including malignancy or serious injury (survival expected to be <1 year) or a significant cardiovascular or pulmonary contraindications or any other pre-existing conditions that restricts participation in an exercise program 5. Pre-injury immobility or inability to independently weight-bear
Outcome results
None listed