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Body Weight Supported Treadmill Training Following Hip Fracture

Body Weight Supported Treadmill Training Following Hip Fracture

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00197496
Enrollment
21
Registered
2005-09-20
Start date
2007-01-31
Completion date
2008-01-31
Last updated
2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture

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.

Interventions

hip fracture patients walk on a treadmill with body weight support

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up3 monthsCompliance to BWSTT only,

Secondary

MeasureTime frame
Timed up and Godischarge
Falls Self Efficacydischarge
2 Minute Walk Testdischarge
Lower Extremity Functional Scaledischarge

Countries

Canada

Participant flow

Recruitment details

Patients treated for a hip fracture by orthopedic surgeons and admitted to the inpatient rehabilitation floor of a teaching hospital between September 2006 and November 2007 were considered for participation. A break in recruitment was implemented from November to early January to avoid variation in physiotherapy care related to holidays.

Participants by arm

ArmCount
BWSTT
Body weight supported treadmill training
14
Control
Usual care
7
Total21

Withdrawals & dropouts

PeriodReasonFG000FG001
Baseline to DischargeMRSA10
Baseline to Dischargenot interested10
Baseline to DischargePhysician Decision01
Baseline to DischargeProtocol Violation01
Follow-upLost to Follow-up21

Baseline characteristics

CharacteristicBWSTTTotalControl
2 Minute Walk Test time18.7 metres
STANDARD_DEVIATION 18.9
20.6 metres
STANDARD_DEVIATION 17.3
23.6 metres
STANDARD_DEVIATION 15.3
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
14 Participants21 Participants7 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous79.9 years
STANDARD_DEVIATION 7
81.2 years
STANDARD_DEVIATION 7
83.7 years
STANDARD_DEVIATION 8.6
Falls Self-efficacy Scale22.4 units on a scale
STANDARD_DEVIATION 9.2
22.2 units on a scale
STANDARD_DEVIATION 8.7
22.0 units on a scale
STANDARD_DEVIATION 8.2
Lower Extremity Functional Score16.6 units on a scale
STANDARD_DEVIATION 8
19.7 units on a scale
STANDARD_DEVIATION 11.9
25.7 units on a scale
STANDARD_DEVIATION 16.5
Sex: Female, Male
Female
12 Participants18 Participants6 Participants
Sex: Female, Male
Male
2 Participants3 Participants1 Participants
Timed up and go time73.9 seconds
STANDARD_DEVIATION 29.1
64.8 seconds
STANDARD_DEVIATION 27.8
45.6 seconds
STANDARD_DEVIATION 10.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 120 / 5
serious
Total, serious adverse events
0 / 120 / 5

Outcome results

Primary

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

Compliance to BWSTT only,

Time frame: 3 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BWSTTFeasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up# with at least 60% compliance6 Participants
BWSTTFeasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up# agreed to participate14 Participants
BWSTTFeasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up#returned for 3 month followup10 Participants
Secondary

2 Minute Walk Test

Time frame: discharge

ArmMeasureValue (MEAN)Dispersion
BWSTT2 Minute Walk Test70.6 metresStandard Deviation 17.3
Control2 Minute Walk Test79.4 metresStandard Deviation 17.9
Secondary

Falls Self Efficacy

Time frame: discharge

ArmMeasureValue (MEAN)Dispersion
BWSTTFalls Self Efficacy17.7 units on a scaleStandard Deviation 6.6
ControlFalls Self Efficacy12.8 units on a scaleStandard Deviation 4.4
Secondary

Lower Extremity Functional Scale

Time frame: discharge

ArmMeasureValue (MEAN)Dispersion
BWSTTLower Extremity Functional Scale35.3 units on a scaleStandard Deviation 7.5
ControlLower Extremity Functional Scale46.4 units on a scaleStandard Deviation 7.2
p-value: 0.495% CI: [-3.6, 9.2]Regression, Linear
Secondary

Timed up and Go

Time frame: discharge

ArmMeasureValue (MEAN)Dispersion
BWSTTTimed up and Go25.2 secondsStandard Deviation 7
ControlTimed up and Go20.7 secondsStandard Deviation 5
p-value: <0.0595% CI: [-72.1, 19.6]Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026