Phase 1 N=10 Treatment

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

Stroke · Hemiplegic Gait

Bottom Line

View on ClinicalTrials.gov: NCT01811680 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: 6 Minute Walk Test (Metres) — 54.3 metres

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Variable Speed and Sensing Treadmill (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Tan Tock Seng Hospital
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY 6 Minute Walk Test (Metres)	54.3	—
PRIMARY 10 Meter Walk Test	0.06	—

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.

Eligibility Criteria

Inclusion Criteria

First ever stroke (ischaemic or haemorrhagic) confirmed on Computed Tomography or Magnetic Resonance imaging
Aged 21 - 80 years
Stroke duration of >3 months in outpatient phase (subacute -chronic stroke)
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.
Functional ambulation category (FAC >/= 2) (Holden et al 1994)

Exclusion Criteria

Cardiovascular conditions such as uncontrolled hypertension/hypotension, angina pectoris, recent myocardial infarction, congestive cardiac failure, known echocardiographic ejection fraction 5/10, fixed orthopaedic deformities of the lower limb which would compromise safe ambulation on treadmill.
Moderate to severe lower limb spasticity or spasms (Modified Ashworth Scale >2)
Active trunk skin conditions, known abdominal aortic aneurysm, anticoagulation with warfarin precluding safe fit of gait harness

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01811680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.