Effectiveness of Home-based Rehabilitation Program
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|ClinicalTrials.gov Identifier: NCT04108793|
Recruitment Status : Not yet recruiting
First Posted : September 30, 2019
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fall||Other: Physiotherapy exercises||Not Applicable|
Hip fractures are a major health problem globally and are associated with increased morbidity, mortality, and substantial economic costs. Successful operative treatment of hip fracture patients is necessary for the optimization of post-op mobility and functional recovery of the patient. Rehabilitation after surgical stabilization of a hip fracture is crucial in order to restore pre-fracture function and to avoid long-term institutionalization. The probability of long-term confinement can be as high as 25% if the fracture is not fixed.
The combination of high incidence of fall and a high susceptibility to injury is a major public health concern among elderly population. This propensity for fall-related injury in elderly persons stems from a high prevalence of co morbid diseases such as osteoporosis and age-related physiological decline (e.g. slower reflexes) that make even a relatively mild fall, potentially dangerous The development and implementation of effective strategies to minimize disability and falls among older people is an urgent public health challenge due to the increasing proportion of older people in the global population. Besides, for many individuals, the risk of falls and disability after hospital discharge decreases with time. However, for a significant proportion, this is not the case. Many patients after discharge are readmitted with second fracture to the hospitals due to lack of acute rehabilitation programs. Therefore, we have designed a post-discharge home-based physical rehabilitation intervention program to minimize disability and falls in this high-risk elderly population.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||This study is an open label trial where patients, orthopedic surgeons, Nurses, and physical therapist will be aware of the intervention group. Therefore, no blinding or allocation concealment will be performed. However, the research assistant who will assess incidence of fall on telephone call will be kept blinded to ensure blinded data assessing.|
|Official Title:||Effectiveness of Home-based Rehabilitation Program in Minimizing Disability and Secondary Falls After a Hip Fracture: A Randomized Controlled Trial|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: Intervention Arm
The Intervention group will be given a program of progressive balance and lower limb strengthening exercises twice a week for 3 months. All exercises will include 5 minutes warm-up exercises. The lower limb extensor muscle groups (hip & knee extensors and ankle plantar flexors) will be targeted with exercises designed to enhance postural control (i.e. balance) and muscle strength. The balance exercises include standing with a decreased base of support, forwards and sideways stepping/walking, and graded reaching activities in standing. Strengthening exercises will include sit-to-stand, forward and lateral step-ups onto a small block, semi squats and heel raises in standing. Standard principles governing frequency, volume, duration, intensity and progression of exercise will be applied. Cueing strategies will be used to reduce freezing. T
Other: Physiotherapy exercises
The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge funded by the study.
No Intervention: Control Arm
The control arm will receive the usual standard postoperative rehabilitation after a bipolar hemiarthroplasty/ total hip arthroplasty which will include in hospital rehabilitation and a maximum of 5 visits postoperatively
- occurrence of secondary fall. [ Time Frame: All the Patients (both groups) will be contacted after every 3 months for the period of two years via telephone call to assess occurrence of fall ]
The Primary outcome of the study is occurrence secondary fall. Follow-ups will be done 3 monthly by research-assistant using telephone calls for both the groups to assess if occurrence of secondary fall. A fall will be defined according to the Kellogg definition as an incident in which the body unintentionally comes to rest on the ground or other lower level which is not as a result of a violent blow, loss of consciousness, and sudden onset of paralysis as in a stroke or an epileptic seizure.
Falls will be assessed by comparing the number of falls in intervention and control groups. The occurrence of fall in each group will also be compared.
- Physical Mobility and Mobility-related disability [ Time Frame: the performance-based mobility measure will be marked at every routine follow-up for up to two years using face to face interview to assess the overall trend. ]The performance-based mobility measure will be the lower extremity Summary Performance Score version of the Short Physical Performance Battery (SPPB). This battery gives a composite score based on timed performance of three mobility tasks: the ability to stand up for up to 10 seconds with feet in different positions (together side by side, semi-tandem and tandem), 4-meter walk and time to rise from a chair 5 times. The short performance based mobility tool is a valid and reliable tool with test retest validity ranging from 0.83 to 0.89
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108793
|Contact: Shahryar Noordin, MBBS,FCPS||+92 34864384 ext firstname.lastname@example.org|
|Contact: Anum S Pidani, BScN,MSc||+92 34864383 ext email@example.com|
|Principal Investigator:||Shahryar Noordin, MBBS,FCPS||Aga Khan University|