Trial Outcomes & Findings for An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation (NCT NCT01811680)

Last Updated: 2015-01-05

Results Overview

6 minute walk test - assess distance walked within 6 minutes as a sub maximal test of endurance (Assessed at weeks 0,2,4 and 8)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

8 weeks

Results posted on

2015-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Supervised Treadmill Training Supervised treadmill training on variable sensing treadmill. Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supervised Treadmill Training n=10 Participants Supervised treadmill training on variable sensing treadmill. Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training.
Age, Continuous	55.5 years STANDARD_DEVIATION 9.85 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Singapore	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: chronic stroke

6 minute walk test - assess distance walked within 6 minutes as a sub maximal test of endurance (Assessed at weeks 0,2,4 and 8)

Outcome measures

Outcome measures
Measure	Supervised Treadmill Training n=10 Participants Supervised treadmill training on variable sensing treadmill. Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training.
6 Minute Walk Test (Metres)	54.3 metres Standard Deviation 30.9

PRIMARY outcome

Timeframe: 8 weeks

Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)

Outcome measures

Outcome measures
Measure	Supervised Treadmill Training n=10 Participants Supervised treadmill training on variable sensing treadmill. Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training.
10 Meter Walk Test	0.06 m/s Standard Deviation 0.07

Adverse Events

Supervised Treadmill Training

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 Karen Chua

Tan Tock Seng Hospital

Phone: 65 68894580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place