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Clinical Trials/NCT03555474
NCT03555474CompletedNot Applicable

Efficacy of the Theta Burst Stimulation and Functional Electrical Stimulation as Compared to Conventional Physiotherapy in Stroke Rehabilitation: A Randomized Controlled Trial

Sree Chitra Tirunal Institute for Medical Sciences & Technology0 sites60 target enrollmentStarted: October 5, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Primary Endpoint
Fugl Meyer Assessment (FMA) scale

Study Overview

Brief 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.

Detailed Description

Background

Present management strategies involving conventional physiotherapy (PT) have limited efficacy in facilitating the motor recovery following stroke. Finding an effective intervention to improve motor recovery in individuals with hemiplegia is very important for improving the functional outcome and enabling independent living.

Following an injury, the brain undergoes significant reorganization of its functions resulting in functional recovery, which occurs over a period of weeks to months. This postlesional reorganization occurs mostly in the premotor cortex, dorsolateral prefrontal cortex and supplementary motor area which are thought to play the most important role in recovery following any type of brain injury. Treatment approaches which can facilitate this reorganization process by enhancing the cortical plasticity might have a very important role in improving the functional outcome following neuronal injury.

Both central and peripheral stimulation has potential to improve the cortical reorganization and functional recovery following acute stroke. Previous studies have established that following an acute stroke, the depressed excitability of the ipsilesional hemisphere can be increased by stimulating the ipsilesional hemisphere or by inhibiting the contralesional hemisphere.This happens because of the fact that one hemisphere has inhibitory effect on the other hemisphere through transcallosal inhibition. In preliminary studies, application of high frequency repetitive transcranial magnetic stimulation (rTMS) to motor cortex has been shown to produce an increase in corticospinal excitability leading to enhancement of motor functions. Theta Burst Stimulation (TBS), which is a novel method of delivering rTMS at lower intensities without the risk of any major adverse effects, has been found to be safe in chronic and acute stroke patients. In this regard, intermittent TBS (iTBS) has a stimulatory effect on the brain and continuous TBS (cTBS) has inhibitory effect on the brain. In preliminary studies, intermittent TBS (iTBS) applied to the ipsilesional hemisphere and continuous TBS (cTBS) applied to the contralesional hemisphere have been shown to improve the motor functions and corticospinal output in the paretic hands during experimental settings. However, long term effects of this strategy on functional outcome have not been previously studied. Similarly, functional electrical stimulation (FES), a form of peripheral stimulation, when applied to the paretic upper limb muscles has been shown to improve the upper limb functional activity in patients with acute or subacute stroke.

Thus both the TBS and FES has a potential of improving the motor functions and the functional outcome following ischemic stroke. However, these strategies have not been used in clinical setting and their usefulness in promoting motor recovery over and above that of conventional PT has not been proven. If proven to be useful, these techniques have a potential of improving the otherwise dismal functional outcome following stroke. The purpose of this study is to determine efficacy of TBS or FES as an adjunctive to physical therapy for the rehabilitation of stroke patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Outcome assessor was blinded to the type of intervention.

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •First episode of ischemic stroke in the internal carotid artery territory defined on CT scan or MRI brain.
  • •Presentation within 7 days to 1 month of stroke onset.
  • •Age group between 18-70 years
  • •Muscle power less than 3 according to Medical Research Council (MRC) Grading

Exclusion Criteria

  • •Brain stem stroke
  • •Bilateral strokes
  • •Hemorrhagic stroke
  • •Significant joint deformity preventing effective physiotherapy
  • •Severe internal carotid artery stenosis requiring intervention
  • •Unstable cardiopulmonary status and other diseases which are likely to hamper the 1 year follow up
  • •Patients with contraindication to transcranial magnetic stimulation
  • •Patients with previous history of seizures
  • •Patients on chronic anti-psychiatric and antidepressants drugs

Arms & Interventions

Theta burst stimulation & Physiotherapy

Experimental

Patients were given theta burst stimulation (intermittent TBS (iTBS) to the affected hemisphere and continuous TBS (cTBS) to the unaffected hemisphere) along with physiotherapy. TBS was delivered for 3 times in a week for 4 weeks.The stimulation was given with an intensity of 60% of RMT. The iTBS protocol of 10 bursts of high-frequency stimulation (3 pulses at 50 Hz) was applied at 5 Hz every 10 second for a total of 600 pulses.

Continuous TBS (inhibitory) was delivered to the unaffected hemisphere at the "hot-spot" with an intensity of 60% of RMT, 3 pulses at 50 Hz, repeated every 200 ms for a total of 600 pluses.

Intervention: Theta burst stimulation (Procedure)

Theta burst stimulation & Physiotherapy

Experimental

Patients were given theta burst stimulation (intermittent TBS (iTBS) to the affected hemisphere and continuous TBS (cTBS) to the unaffected hemisphere) along with physiotherapy. TBS was delivered for 3 times in a week for 4 weeks.The stimulation was given with an intensity of 60% of RMT. The iTBS protocol of 10 bursts of high-frequency stimulation (3 pulses at 50 Hz) was applied at 5 Hz every 10 second for a total of 600 pulses.

Continuous TBS (inhibitory) was delivered to the unaffected hemisphere at the "hot-spot" with an intensity of 60% of RMT, 3 pulses at 50 Hz, repeated every 200 ms for a total of 600 pluses.

Intervention: Physiotherapy (Procedure)

Functional stimulation & Physiotherapy

Experimental

Patients in the functional electrical stimulation (FES) group received the electrical stimulation with electrodes positioned according to pattern 3 [Grasp/Flexion/Extension, PATT (pattern movement)] of the FES (F) mode of the instrument. The electrodes were connected to a stimulator controller unit that delivers alternating current at a frequency of 35 Hz and a pulse width of 200 µs, intensity 10~50 mA.

The FES group stimulation session was given for 30 minutes for each day 3 times in a week (alternate days) for 4 weeks and it was concurrently synchronized with the physiotherapy.

Intervention: Functional Electrical Stimulation (Procedure)

Functional stimulation & Physiotherapy

Experimental

Patients in the functional electrical stimulation (FES) group received the electrical stimulation with electrodes positioned according to pattern 3 [Grasp/Flexion/Extension, PATT (pattern movement)] of the FES (F) mode of the instrument. The electrodes were connected to a stimulator controller unit that delivers alternating current at a frequency of 35 Hz and a pulse width of 200 µs, intensity 10~50 mA.

The FES group stimulation session was given for 30 minutes for each day 3 times in a week (alternate days) for 4 weeks and it was concurrently synchronized with the physiotherapy.

Intervention: Physiotherapy (Procedure)

Physiotherapy

Active Comparator

The following different physiotherapy regimens were followed for all the patients in the study.

Passive/Active Range of Motion (ROM); Weight bearing and supportive reaction; Reaching activities; Grasping, holding and release; Upper extremity activities of daily living (ADL). Physiotherapy intervention was given to all the patients 5 days per week for 1 month. In addition, all patients continued to receive in-home physiotherapy 1 to 2 times per week by a home physiotherapist who was guided by the research physiotherapist.

Intervention: Physiotherapy (Procedure)

Outcomes

Primary Outcomes

Fugl Meyer Assessment (FMA) scale

Time Frame: One year

Fugl Meyer Assessment (FMA) scale, is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. We used upper limb motor function domain of FMA scale which is a 66 point domain with a score ranging from 0-66. The lower score indicates more severe disability in upper limb motor functions.

Secondary Outcomes

  • National Institute of Health Stroke Scale (NIHSS)(One year)
  • Modified Rankin Scale(One year)
  • Barthel Index(One year)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Dr. Chaturbhuj Rathore

Associate Professor

Sree Chitra Tirunal Institute for Medical Sciences & Technology

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