An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation (VASST)
|ClinicalTrials.gov Identifier: NCT01811680|
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : December 4, 2014
Last Update Posted : January 5, 2015
To conduct a feasibility clinical trial to test a novel patient sensing automated treadmill device devised by local engineers for subacute hemiplegic stroke patients for gait rehabilitation. This is a phase 1 feasibility and safety trial on the above device for 10 chronic stroke patients with hemiparetic gait dysfunction to be conducted over a period of 2 months.
Research protocol and standardized outcomes measures will be used.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiplegic Gait||Device: Variable Speed and Sensing Treadmill||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of "An Exploratory Feasibility Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation in Subacute Stroke Patients."|
|Study Start Date :||August 2012|
|Primary Completion Date :||July 2013|
|Study Completion Date :||July 2013|
Experimental: supervised treadmill training
Supervised treadmill training on variable sensing treadmill.
Device: Variable Speed and Sensing Treadmill
open label study on variable speed and sending treadmill training for hemiplegic gait training.
Other Name: VASST
- 6 Minute Walk Test (Metres) [ Time Frame: 8 weeks ]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)
- 10 Meter Walk Test [ Time Frame: 8 weeks ]Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811680
|TTSH Rehab Medicine, Centre of Advanced Rehablitation Therapeutics (CART) , 11 Jalan Tan Tock Seng Hospital|
|Singapore, Singapore, 308433|
|Principal Investigator:||Chua Karen, MD||Tan Tock Seng Hospital|