Body Weight Supported Treadmill Training Following Hip Fracture - Full Text View

Sponsor:	Hamilton Health Sciences Corporation
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00197496

Purpose

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.

Condition	Intervention	Phase
Hip Fracture	Procedure: Body weight supported treadmill training	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Body Weight Supported Treadmill Training Following Hip Fracture

Resource links provided by NLM:

MedlinePlus related topics: Fractures Hip Injuries and Disorders

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

Feasibility - # participants agreeing to participate, compliance, adverse events, # returning for 3 month follow-up [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Functional Independence Measure [ Time Frame: admission, discharge, follow-up ] [ Designated as safety issue: No ]
Timed up and Go [ Time Frame: admission, discharge, follow-up ] [ Designated as safety issue: No ]
falls self efficacy [ Time Frame: baseline, discharge, 3 month follow-up ] [ Designated as safety issue: No ]
2 minute walk test [ Time Frame: baseline, discharge, 3 month follow-up ] [ Designated as safety issue: No ]
lower extremity functional scale [ Time Frame: baseline, discharge, 3 month followup ] [ Designated as safety issue: No ]

Enrollment:	21
Study Start Date:	January 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Intervention Details:

hip fracture patients walk on a treadmill with body weight support

Other Name: treadmill training

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197496

Locations

Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L9C7N4

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Investigators

Principal Investigator:	Lora Giangregorio, PhD	University of Waterloo
Principal Investigator:	Alexandra Papaioannou, MD, MSc	Hamilton Health Sciences and McMaster University

More Information

No publications provided

Responsible Party:	Alexandra Papaioannou, McMaster University
ClinicalTrials.gov Identifier:	NCT00197496 History of Changes
Other Study ID Numbers:	NIF-05055
Study First Received:	September 12, 2005
Last Updated:	September 19, 2009
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Body Weight
Fractures, Bone
Hip Fractures
Signs and Symptoms

Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on February 09, 2012