The effect of non invasive auricular vagus nerve stimulation (taVNS) combined with physiotherapy on mobility and balance impairment after stroke.

Not Applicable

Recruiting

• Conditions: Stroke; Gait impairments; Balance impairments; Physical Medicine / Rehabilitation - Physiotherapy; Neurological - Studies of the normal brain and nervous system; Cardiovascular - Other cardiovascular diseases; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12623000376640
• Lead Sponsor: niversity of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-13
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Aged 18 years or older; first-ever haemorrhagic or ischaemic stroke at least 6 months earlier; can walk 10 meters with or without a gait aid and with or without assistance, no history of other neurological conditions; gait and/or balance impairment; ability to give informed consent and to understand instruction.

Exclusion Criteria

Previous vagus nerve surgery; cognitive impairment and/or language impairment that might impact the person's ability to consent or understand instructions (MOCA score of less than 18) ; severe pain in any joints of the affected limb; advanced cardiac, pulmonary, kidney or liver condition; pregnancy; active implants; cerebral shunts; open skin at the point of stimulation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is the feasibility of taVNS as an adjuvant therapy to enhance balance and gait recovery in chronic stroke. This will be determined by measuring recruitment rates and compliance to intervention determined by study logs, patients' acceptability and satisfaction of the intervention (determine using 5-point Likert Scale), adverse events, and effectiveness of blinding. Two questionnaires have been developed to assess adverse events and effectiveness of sham methods (both are included in attached study protocol). All feasibility measures will be assessed as a composite primary outcome. If all feasibility criteria described in detail in Table 1 of attached study protocol met the requirement to proceed or proceed with protocol amendment then the study will be deemed feasible. [ Within five days of last intervention session.]