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

Phase 1

Completed

• Conditions: Stroke; Hemiplegic Gait
• Interventions: Device: Variable Speed and Sensing Treadmill

• Registration Number: NCT01811680
• Lead Sponsor: Tan Tock Seng Hospital

Brief 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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2014-09-12
• Results First Submitted QC: 2014-11-26
• Results First Posted: 2014-12-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-02
• Last Update Posted: 2015-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. First ever stroke (ischaemic or haemorrhagic) confirmed on Computed Tomography or Magnetic Resonance imaging
2. Aged 21 - 80 years
3. Stroke duration of >3 months in outpatient phase (subacute -chronic stroke)
4. Able to walk overground at a self-selected speed of >0.2m/s with or without walking aids or lower limb orthoses for at least 150 meters with contact guard or supervision.
5. Functional ambulation category (FAC >/= 2) (Holden et al 1994)

Exclusion Criteria

1. Cardiovascular conditions such as uncontrolled hypertension/hypotension, angina pectoris, recent myocardial infarction, congestive cardiac failure, known echocardiographic ejection fraction < 40% within 3 months of stroke, chronic arrhythmias (e.g. atrial fibrillation) within 3 months of study screening, pacemaker, uncontrolled Diabetes Mellitus.
2. End stage illness (advanced malignancy), pregnancy or end stage renal failure with life expectancy of <6 months.
3. Aphasia (inability to obey 2 step commands), communication disorder precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
4. Active lower limb arthritis, Pain (Visual Analogue Scale) >5/10, fixed orthopaedic deformities of the lower limb which would compromise safe ambulation on treadmill.
5. Moderate to severe lower limb spasticity or spasms (Modified Ashworth Scale >2)
6. Active trunk skin conditions, known abdominal aortic aneurysm, anticoagulation with warfarin precluding safe fit of gait harness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
supervised treadmill training	Variable Speed and Sensing Treadmill	Supervised treadmill training on variable sensing treadmill.

Primary Outcome Measures

Name	Time	Method
6 Minute Walk Test (Metres)	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	8 weeks	Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)

Trial Locations

Locations (1)

TTSH Rehab Medicine, Centre of Advanced Rehablitation Therapeutics (CART) , 11 Jalan Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore