Clinical trial NCT00197496: Body Weight Supported Treadmill Training Following Hip Fracture
Official title: Body Weight Supported Treadmill Training Following Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Achieving independent ambulation is an important goal of hip fracture rehabilitation, as it is predictive of returning to the community and of future health problems. Current research regarding post-hip fracture rehabilitation is sparse. Body weight supported treadmill training (BWSTT) is a novel approach to retrain walking abilities. BWSTT may be ideal for retraining walking after hip fracture, as it is task-specific and alleviates the demands of maintaining balance while walking skills are trained. The use of the harness may provide a sense of security for the patient, facilitating walking training. The proposed project will investigate the feasibility and tolerability of BWSTT after hip fracture, and its impact on function, mobility, quality of life and fear of falling. It is hypothesized that BWSTT 3-5 times weekly in acute hip fracture patients will improve function, mobility, quality of life and reduce fear of falling.

Detailed description: Morbidity and mortality rates associated with hip fracture are enormous. Current literature regarding post-hip fracture rehabilitation is sparse. A recent Cochrane review suggested that the potential for enhancing the recovery of mobility in hip fracture patients with treadmill gait retraining warrants further research in this area. Body weight supported treadmill training (BWSTT) is a novel approach to retraining ambulation, and has been successfully implemented in other patient populations. BWSTT may be ideal for retraining gait after hip fracture, as it is task-specific and alleviates the demands of maintaining equilibrium while walking skills are trained. The objectives of the proposed pilot study are to evaluate the feasibility and tolerability of using BWSTT as a gait retraining strategy in individuals who have experienced a hip fracture, and to explore whether it can improve mobility, fear of falling and function. Participants' feedback will be sought regarding the BWSTT experience for use in planning future clinical trials, to be submitted to CIHR. Quantitative outcomes will be assessed at baseline, and after 4 weeks of training 3-5 times per week. Outcome measures include: the Lower Extremity Functional Scale, health-related quality of life (SF-36), Falls-Efficacy Scale and the 2-minute walk test. Based on previous research experience with the frail elderly, we anticipate that many patients will be receptive to rehabilitation in the form of BWSTT. We hypothesize that BWSTT after hip fracture will result in significant gains in ambulatory capacity, as well as improvements in quality of life and functional independence. In addition, we anticipate that BWSTT will prove to be a feasible and effective gait retraining strategy.

Eligibility criteria: Inclusion Criteria:

* Able to follow 2-step commands
* Stable inter-trochanteric fracture, where fixation is deemed by surgeon to be adequate, OR sub-capital fracture having undergone bipolar hemi-arthroplasty
* Able to stand and take a few steps with the help of an assistive device i.e. parallel bars, walker, or cane

Exclusion Criteria:

* Able to walk without assistive devices
* Hip, knee or ankle surgery prior to hip fracture
* Inability to understand instructions or give informed consent
* Uncontrolled cardiovascular disease or hypertension, diabetes, neuromuscular disease or other musculoskeletal disease such as rheumatoid arthritis, Uncontrolled pain

Primary outcomes:
measure: Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Timed up and Go
timeFrame: discharge
measure: Falls Self Efficacy
timeFrame: discharge
measure: 2 Minute Walk Test
timeFrame: discharge
measure: Lower Extremity Functional Scale
timeFrame: discharge
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Lora Giangregorio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences and McMaster University
name: Alexandra Papaioannou, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giangregorio LM, Thabane L, Debeer J, Farrauto L, McCartney N, Adachi JD, Papaioannou A. Body weight-supported treadmill training for patients with hip fracture: a feasibility study. Arch Phys Med Rehabil. 2009 Dec;90(12):2125-30. doi: 10.1016/j.apmr.2009.06.022.