Trial Outcomes & Findings for Body Weight Supported Treadmill Training Following Hip Fracture (NCT NCT00197496)

NCT ID: NCT00197496

Last Updated: 2017-03-30

Results Overview

Compliance to BWSTT only,

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2017-03-30

Participant Flow

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.

Participant milestones

Measure	BWSTT Body weight supported treadmill training	Control Usual care
Baseline to Discharge STARTED	14	7
Baseline to Discharge COMPLETED	12	5
Baseline to Discharge NOT COMPLETED	2	2
Follow-up STARTED	12	5
Follow-up COMPLETED	10	4
Follow-up NOT COMPLETED	2	1

Reasons for withdrawal

Measure	BWSTT Body weight supported treadmill training	Control Usual care
Baseline to Discharge not interested	1	0
Baseline to Discharge MRSA	1	0
Baseline to Discharge Physician Decision	0	1
Baseline to Discharge Protocol Violation	0	1
Follow-up Lost to Follow-up	2	1

Baseline Characteristics

Some participants could not complete performance based measures at baseline.

Baseline characteristics by cohort

Measure	BWSTT n=14 Participants Body weight supported treadmill training	Control n=7 Participants Usual care	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	14 Participants n=14 Participants	7 Participants n=7 Participants	21 Participants n=21 Participants
Age, Continuous	79.9 years STANDARD_DEVIATION 7.0 • n=14 Participants	83.7 years STANDARD_DEVIATION 8.6 • n=7 Participants	81.2 years STANDARD_DEVIATION 7 • n=21 Participants
Sex: Female, Male Female	12 Participants n=14 Participants	6 Participants n=7 Participants	18 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=14 Participants	1 Participants n=7 Participants	3 Participants n=21 Participants
Timed up and go time	73.9 seconds STANDARD_DEVIATION 29.1 • n=8 Participants • Some participants could not complete performance based measures at baseline.	45.6 seconds STANDARD_DEVIATION 10.3 • n=4 Participants • Some participants could not complete performance based measures at baseline.	64.8 seconds STANDARD_DEVIATION 27.8 • n=12 Participants • Some participants could not complete performance based measures at baseline.
2 Minute Walk Test time	18.7 metres STANDARD_DEVIATION 18.9 • n=11 Participants • Some participants could not perform performance based measures at baseline	23.6 metres STANDARD_DEVIATION 15.3 • n=7 Participants • Some participants could not perform performance based measures at baseline	20.6 metres STANDARD_DEVIATION 17.3 • n=18 Participants • Some participants could not perform performance based measures at baseline
Lower Extremity Functional Score	16.6 units on a scale STANDARD_DEVIATION 8 • n=14 Participants	25.7 units on a scale STANDARD_DEVIATION 16.5 • n=7 Participants	19.7 units on a scale STANDARD_DEVIATION 11.9 • n=21 Participants
Falls Self-efficacy Scale	22.4 units on a scale STANDARD_DEVIATION 9.2 • n=14 Participants	22.0 units on a scale STANDARD_DEVIATION 8.2 • n=7 Participants	22.2 units on a scale STANDARD_DEVIATION 8.7 • n=21 Participants

PRIMARY outcome

Timeframe: 3 months

Compliance to BWSTT only,

Outcome measures

Measure	BWSTT n=14 Participants Body weight supported treadmill training	Control Usual care
Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up # agreed to participate	14 Participants	—
Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up #returned for 3 month followup	10 Participants	—
Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up # with at least 60% compliance	6 Participants	—

SECONDARY outcome

Timeframe: discharge

Outcome measures

Measure	BWSTT n=12 Participants Body weight supported treadmill training	Control n=5 Participants Usual care
Timed up and Go	25.2 seconds Standard Deviation 7.0	20.7 seconds Standard Deviation 5.0

SECONDARY outcome

Timeframe: discharge

Outcome measures

Measure	BWSTT n=12 Participants Body weight supported treadmill training	Control n=5 Participants Usual care
Falls Self Efficacy	17.7 units on a scale Standard Deviation 6.6	12.8 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: discharge

Outcome measures

Measure	BWSTT n=8 Participants Body weight supported treadmill training	Control n=5 Participants Usual care
2 Minute Walk Test	70.6 metres Standard Deviation 17.3	79.4 metres Standard Deviation 17.9

SECONDARY outcome

Timeframe: discharge

Outcome measures

Measure	BWSTT n=12 Participants Body weight supported treadmill training	Control n=5 Participants Usual care
Lower Extremity Functional Scale	35.3 units on a scale Standard Deviation 7.5	46.4 units on a scale Standard Deviation 7.2

Adverse Events

BWSTT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lora Giangregorio

University of Waterloo

Phone: 5198884567

Email: lmgiangr@uwaterloo.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place