Anodal TDCS and Postural Stability in Subacute Stroke

NCT ID: NCT05903599

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2024-01-31

Brief Summary

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Stroke patients experience weakening of muscles on the affected side. Damage to the motor cortex and the pyramidal tract due to a stroke leads to a motor control disorders and co-contraction of trunk muscles due to abnormal levels of abdominal muscle tension and voluntary movement.

Detailed Description

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TDCS is known to modulate motor excitability in humans and motor performance is crucial in postural control. Studies reports that applying anodal TDCS to the ipsilesional motor cortex improved motor functioning in which the Transcranial Direct Current Stimulation may have stimulated preserved areas of the motor cortex to enhance synaptic efficiency along the corticospinal tract.

Anodal TDCS has been shown to have immediate and short-term effects in stroke but its long-term effects in stroke are still unclear. Additionally, the available literature focuses on acute and chronic stages of stroke so we will target subacute stage of stroke. Therefore, this study is designed to investigate the short and long-term effects of Anodal Transcranial Direct Current Stimulation on postural stability in subacute stroke.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

anodal Transcranial direct current stimulation with saline soaked sponges will be used on electrodes, for 20 mins in addition to the 60 mins of conventional treatment.

Group Type EXPERIMENTAL

Anodal transcranial direct current stimulation

Intervention Type OTHER

The size of both electrodes will be 5cm x 5cm placed on the head with the anode on the primary motor cortex M1 of the affected side while the cathode on the contralesional eye. The duration of the stimulation of anodal TDCS is 20 min and the intensity of current will be 2mA. The ramp up and down period will be 30se each. Treatment duration will be 5 times a week for 6 weeks for postural stability.

Group B

A sham stimulation will be given. It will be comprised 20 min of sham TDCS followed by 60 mins of conventional treatment for postural stability in sub-acute stroke

Group Type SHAM_COMPARATOR

Sham Stimulation

Intervention Type OTHER

postural training by visual feedback and weight shifting towards the non-paretic side. This program will have two phases. Phase one have 4 stages; The first stage (sessions 1-7), second stage (sessions 8-14), third stage (sessions 15-22), fourth stage (sessions 23-30).

Next phase will include the exercises including balancing exercises.

Interventions

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Anodal transcranial direct current stimulation

The size of both electrodes will be 5cm x 5cm placed on the head with the anode on the primary motor cortex M1 of the affected side while the cathode on the contralesional eye. The duration of the stimulation of anodal TDCS is 20 min and the intensity of current will be 2mA. The ramp up and down period will be 30se each. Treatment duration will be 5 times a week for 6 weeks for postural stability.

Intervention Type OTHER

Sham Stimulation

postural training by visual feedback and weight shifting towards the non-paretic side. This program will have two phases. Phase one have 4 stages; The first stage (sessions 1-7), second stage (sessions 8-14), third stage (sessions 15-22), fourth stage (sessions 23-30).

Next phase will include the exercises including balancing exercises.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ischemic stroke
* Sub-acute stroke
* Minimum score of 18 on PASS

Exclusion Criteria

Hearing and Visual loss/ deficit

* Recurrent CVA
* Neurological condition affects the cognition
* Wound at skull
* Presence of shunt and/or metallic implant at cranial region
* Brain tumors
* Musculoskeletal conditions/ surgery in the lower extremities
* Cognitively compromised
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mirza Obaid Baig, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Saeys W, Vereeck L, Lafosse C, Truijen S, Wuyts FL, Van De Heyning P. Transcranial direct current stimulation in the recovery of postural control after stroke: a pilot study. Disabil Rehabil. 2015;37(20):1857-63. doi: 10.3109/09638288.2014.982834. Epub 2015 Jul 9.

Reference Type BACKGROUND
PMID: 25401406 (View on PubMed)

Halmi Z, Stone TW, Dinya E, Mally J. Postural instability years after stroke. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105038. doi: 10.1016/j.jstrokecerebrovasdis.2020.105038. Epub 2020 Jun 23.

Reference Type BACKGROUND
PMID: 32807450 (View on PubMed)

Bornheim S, Croisier JL, Maquet P, Kaux JF. Transcranial direct current stimulation associated with physical-therapy in acute stroke patients - A randomized, triple blind, sham-controlled study. Brain Stimul. 2020 Mar-Apr;13(2):329-336. doi: 10.1016/j.brs.2019.10.019. Epub 2019 Oct 31.

Reference Type BACKGROUND
PMID: 31735645 (View on PubMed)

Other Identifiers

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REC01353 Somia Shakeb

Identifier Type: -

Identifier Source: org_study_id

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