Body Weight Supported Treadmill Training Following Hip Fracture

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00197496
First received: September 12, 2005
Last updated: September 19, 2009
Last verified: September 2009
  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 2

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:


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:
    Procedure: Body weight supported treadmill training
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014