This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Body Weight Supported Treadmill Training Following Hip Fracture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lora Giangregorio, McMaster University
ClinicalTrials.gov Identifier:
NCT00197496
First received: September 12, 2005
Last updated: March 29, 2017
Last verified: March 2017
  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
Hip Fracture Procedure: Body weight supported treadmill training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Lora Giangregorio, McMaster University:

Primary Outcome Measures:
  • Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up [ Time Frame: 3 months ]
    Compliance to BWSTT only,


Secondary Outcome Measures:
  • Timed up and Go [ Time Frame: discharge ]
  • Falls Self Efficacy [ Time Frame: discharge ]
  • 2 Minute Walk Test [ Time Frame: discharge ]
  • Lower Extremity Functional Scale [ Time Frame: discharge ]

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)
Arms Assigned Interventions
Experimental: BWSTT
Body weight supported treadmill training
Procedure: Body weight supported treadmill training
hip fracture patients walk on a treadmill with body weight support
Other Name: treadmill training
No Intervention: Usual care
Usual care

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
McMaster University
Investigators
Principal Investigator: Lora Giangregorio, PhD University of Waterloo
Principal Investigator: Alexandra Papaioannou, MD, MSc Hamilton Health Sciences and McMaster University
  More Information

Publications:
Responsible Party: Lora Giangregorio, Postdoctoral fellow/Affiliate Scientist, McMaster University
ClinicalTrials.gov Identifier: NCT00197496     History of Changes
Other Study ID Numbers: NIF-05055
Study First Received: September 12, 2005
Results First Received: December 14, 2016
Last Updated: March 29, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Body Weight
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Signs and Symptoms

ClinicalTrials.gov processed this record on September 19, 2017