An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation (VASST)
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|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|
|Actual Primary Completion Date :||July 2013|
|Actual 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|