NCT00197496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

March 30, 2017

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

September 12, 2005

Results QC Date

December 14, 2016

Last Update Submit

March 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Compliance to BWSTT only,

    3 months

Secondary Outcomes (4)

  • Timed up and Go

    discharge

  • Falls Self Efficacy

    discharge

  • 2 Minute Walk Test

    discharge

  • Lower Extremity Functional Scale

    discharge

Study Arms (2)

BWSTT

EXPERIMENTAL

Body weight supported treadmill training

Procedure: Body weight supported treadmill training

Usual care

NO INTERVENTION

Usual care

Interventions

hip fracture patients walk on a treadmill with body weight support

Also known as: treadmill training
BWSTT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L9C7N4, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Limitations and Caveats

It was not possible to blind outcome assessors. We did not randomize participants because we wanted a minimum of 12 to test feasibility of intervention. Control group had a longer average length of stay, and may have received more physiotherapy.

Results Point of Contact

Title
Dr. Lora Giangregorio
Organization
University of Waterloo

Study Officials

  • Lora Giangregorio, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR
  • Alexandra Papaioannou, MD, MSc

    Hamilton Health Sciences and McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral fellow/Affiliate Scientist

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 30, 2017

Results First Posted

March 30, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations