|- candidate number||28130|
|- NTR Number||NTR6794|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-okt-2017|
|- Secondary IDs||E9655 Eurostars|
|- Public Title||Rehabilitation after hip fractures in elderly|
|- Scientific Title||COMplex Fracture Orthopedic Rehabilitation - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in elderly: a randomized controlled trial|
|- hypothesis||The hypothesis is that participants in the intervention group will rehabilitate better (i.e. improvement in gait parameters) and faster, which could reduce healthcare costs significantly.|
|- Healt Condition(s) or Problem(s) studied||Biofeedback, Proximal femoral fracture, Weight bearing|
|- Inclusion criteria||1. The participants rehabilitate from a proximal femur fracture following low energy trauma (e.g. fall from standing position).|
2. The participants have a prescribed unrestricted weight bearing after (surgical) treatment of their fracture.
3. The participants have an expected clinical rehabilitation duration of ≥2 weeks.
4. The participants are ≥60 years.
5. The participants have a bodyweight ≤120 kilogram.
|- Exclusion criteria||1. People with cognitive impairment, defined as a score <18 on the Mini-Mental State Examination.|
2. People who are readmitted to the hospital within two weeks after study participation, for example for infectious complications.
3. People with co-morbidities that affected gait significantly prior to the proximal femur fracture.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2017|
|- planned closingdate||1-aug-2018|
|- Target number of participants||186|
|- Interventions||Participants in the intervention group receive, in addition to the standard institutional protocol, real-time, visual feedback about weight bearing during the 30-meter walk. The physical therapist has real-time, visual insight in the weight bearing as well. The target weight will be set at 100% bodyweight, as the participants have no restrictions in weight bearing. Both the biofeedback system (visually) and the physical therapist (verbally) assist and/or motivate the participant to adapt the weight bearing to the optimal level. |
|- Primary outcome||The primary outcome measures are the SensiStep parameters maximum peak load (in %bodyweight) and step duration (in seconds), which will be correlated with the discharge date from the rehabilitation center. It will be investigated if higher maximum peak loads and shorter step durations correlate with the end of rehabilitation (i.e. discharge date). |
|- Secondary outcome||Secondary outcomes include other spatio-temporal gait parameters and validated clinical tests, including the Elderly Mobility Scale (EMS), the Functional Ambulation Categories (FAC) and the Visual Analogue Scale (VAS). Spatio-temporal gait parameters measured by the SensiStep will be correlated to the mobility scores (e.g. EMS, FAC and VAS). |
|- Timepoints||The institutional protocol for physical therapy after proximal femur fractures will be followed in all participants. In addition, each participant receives daily force measurements using the SensiStep system in a 30-meter walk to monitor the weight bearing. Additional clinical tests will be executed to gain additional insight in the rehabilitation progress of each participant:|
1. Functional Ambulation Categories (1x per week)
2. Elderly Mobility Scale (2x per week)
3. Visual Analogue Scale (daily)
|- Trial web site||www.comfort-project.com|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc M. Raaben|
|- CONTACT for SCIENTIFIC QUERIES||MSc M. Raaben|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Eurostars-2 joint programme, European Union Horizon 2020 Research and Innovation Programme|
|- Brief summary||Each year 610,000 Europeans incur a hip fracture. This number is rising with the aging population. Their
rehabilitation is hampered by absence of proper tools. COMFORT will meet an existing market need for systems
and programs that optimize the rehabilitation process of hip fracture patients. This is of interest for both business
and for improvement in healthcare. The business case aligns with objectives of healthcare organizations in many
countries that have incentives to shorten treatments.|
COMFORT creates a rehabilitation program for patients with hip fractures. This program will help these patients
rehabilitate faster. The rehabilitation program is supported by several innovations: a force sensor system SensiStep, for daily use during regular exercise routines and an app with intelligent software that each day determines the optimal loading target for the patient from the measurements of the force sensor.
The project uses an innovative (CE approved) sensor system (SensiStep) that was recently developed and that is now used during physical therapy in rehabilitation clinics. This system monitors the force (loading) that a patient exerts during ambulant exercises, and can show the therapist if the prescribed loading goal has been achieved correctly.
COMFORT will deliver knowledge about the optimum loading pattern of hip fracture patients. This will be captured in a smart operator in the app of the rehabilitation program. This program will be validated in a randomized controlled trial.
|- Main changes (audit trail)|
|- RECORD||31-okt-2017 - 19-nov-2017|