NCT01811680

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

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."

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 device incorporates patient automated variable speeds and feedback, increased safety features with patient support harness and visual feedback providing ambulatory gait monitoring data. Methodology: 10 stable subacute hemiparetic stroke subjects will undergo supervised treadmill training using this device targeted at improving gait speed and walking independence. Outcomes will be measured at 4 time points pre and post training using clinical scales and temporal-spatial gait measurements. Importance of research to medicine: This study tests the possibility of patient initiated control and closed loop sensing feedback system to provide increased intensity, reduced risk of gait destabilisation and fall risk which are associated with current fixed treadmill training. Potential benefits with new device: Ability to train at self selected variable speeds including fast speeds, improved hemiplegic leg swing initiation and stride length, less assistance required from physiotherapist and reduced fall risk due to overhead safety harness and treadmill sensing and increased patient confidence. Possibility of ambulatory gait speed and force loading during treadmill training. Potential risks: Minor risks of fall are minimised as there is a safety harness and supervision by physiotherapist. Anticipated risks related to repetitive treadmill training with regards to cardiovascular and musculoskeletal side effects will be mitigated with strict patient inclusion and exclusion criteria.

Conditions

• Stroke
• Hemiplegic Gait

Interventions

Type	Name	Description
DEVICE	Variable Speed and Sensing Treadmill	open label study on variable speed and sending treadmill training for hemiplegic gait training.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-03-14
• Last updated: 2015-01-05
• Results posted: 2014-12-04

Locations

1 site across 1 country: Singapore