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Body Weight Supported Treadmill Training Following Hip Fracture

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Body weight supported treadmill training
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BWSTT

Usual care

Arm Description

Body weight supported treadmill training

Usual care

Outcomes

Primary Outcome Measures

Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up
Compliance to BWSTT only,

Secondary Outcome Measures

Timed up and Go
Falls Self Efficacy
2 Minute Walk Test
Lower Extremity Functional Scale

Full Information

First Posted
September 12, 2005
Last Updated
March 29, 2017
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT00197496
Brief Title
Body Weight Supported Treadmill Training Following Hip Fracture
Official Title
Body Weight Supported Treadmill Training Following Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BWSTT
Arm Type
Experimental
Arm Description
Body weight supported treadmill training
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Procedure
Intervention Name(s)
Body weight supported treadmill training
Other Intervention Name(s)
treadmill training
Intervention Description
hip fracture patients walk on a treadmill with body weight support
Primary Outcome Measure Information:
Title
Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up
Description
Compliance to BWSTT only,
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Timed up and Go
Time Frame
discharge
Title
Falls Self Efficacy
Time Frame
discharge
Title
2 Minute Walk Test
Time Frame
discharge
Title
Lower Extremity Functional Scale
Time Frame
discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora Giangregorio, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandra Papaioannou, MD, MSc
Organizational Affiliation
Hamilton Health Sciences and McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9C7N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19969179
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.
Results Reference
result

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Body Weight Supported Treadmill Training Following Hip Fracture

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