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Efficacy of the Theta Burst Stimulation and Functional Electrical Stimulation in Stroke Rehabilitation

NCT03555474 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-15

No results posted yet for this study

Summary

Approximately 50% of patients have persistent motor disability following stroke. Current treatment approaches with conventional physiotherapy have limited efficacy. Repetitive transcranial magnetic stimulation (rTMS) and Functional electrical stimulation (FES) have been shown to improve the neuronal plasticity and motor control in few preliminary studies. Their efficacy in human stroke subjects is unproven. We planned to study their efficacy in improving the motor functions of stroke patients in a randomized trial. Sixty consecutive haemodynamically stable adult patients with first ischemic stroke within last 7-30 days were randomized into three treatment groups to receive either physiotherapy alone, or physiotherapy combined with either FES or rTMS. Outcome was assessed using Fugl Meyer assessment for physical performance of upper limb. Three groups were compared for the outcome measures using intention to treat analysis.

Conditions

  • Strokes Thrombotic

Interventions

PROCEDURE

Theta burst stimulation

Patients were given intermittent TBS to the affected hemisphere and continuous TBS to the unaffected hemisphere for 4 weeks along with physiotherapy.

PROCEDURE

Functional Electrical Stimulation

Patients were given functional electrical stimulation of affected upper extremity for four weeks along with physiotherapy.

PROCEDURE

Physiotherapy

Patients received active and passive physiotherapy of the affected extremity for four weeks.

Sponsors & Collaborators

  • Sree Chitra Tirunal Institute for Medical Sciences & Technology

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-05
Primary Completion
2012-01-25
Completion
2012-01-25

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555474 on ClinicalTrials.gov