Anodal TDCS and Postural Stability in Subacute Stroke

NCT05903599 | Completed

• 1 other identifier: REC01353 Somia Shakeb
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Postural Assessment Scale for Stroke Patients (PASS)

  PASS evaluates the postural imbalance and functional abilities of patients with stroke in several conditions (lying on back, sitting, standing and while changing positions). This scale is composed of 12 items. Score can vary from 0 to 3, with 0 being the lowest level of functionality and 3 the highest; the total score be 36.

  12th week

• Trunk impairment scale (TIS) for Stroke Patients

  It evaluates motor impairment of the trunk after stroke. The TIS scores, on a range from 0 to 23, static and dynamic sitting trunkal stability as well as trunk coordination. It also score the quality of trunk movement and to be a guide for treatment. Number of items are 7, score of each item is 0-3.

  12th week

Secondary Outcomes (3)

• Timed Up and Go Test (TUG)

  12th week

• Functional Reach Test (FRT)

  12th week

• Stroke Specific Quality of life Scale (SS-QoL)

  12th week

Study Arms (2)

Group A

EXPERIMENTAL

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.

Other: Anodal transcranial direct current stimulation

Group B

SHAM COMPARATOR

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

Other: Sham Stimulation

Interventions

Anodal transcranial direct current stimulation 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 A

Sham Stimulation 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.

Group B

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 25401406 BACKGROUND

• 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.

  PMID: 32807450 BACKGROUND

• 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.

  PMID: 31735645 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: May 2, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)