Anodal Transcranial Direct Current Stimulation on Strength in Subacute Stroke

NCT05878626 | Completed

• 1 other identifier: REC01355 Hamad
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Loss of strength is a common complication post stroke which leads to loss of balance and walking ability. Variety of interventions are adopted to improve muscle strength after stroke. These include progressive resistance training, specific task training or functional training, functional electrical stimulation and high intensity aerobic exercises

Conditions

Stroke

Keywords

Strength; Balance

Outcome Measures

Primary Outcomes (1)

• Manual muscle testing

  MMT is used to determine the extent and degree of muscular weakness resulting from disease, injury or disuse. It is an important part of assessment in many patient groups including patients with stroke, spinal cord injury, neuropathy and other neurological and musculoskeletal conditions. The patient can be scored by 5 grades where grade 5 is the patient completes full ROM against maximum resistance from therapist, grade 4 is patient completes full ROM against moderate resistance, grade 3 is patient completes full ROM against gravity, grade 2 is completion of ROM with gravity eliminated, grade 1 is flickering of muscles when movement is attempted and grade 0 is when there is no palpable contraction or flickering. A review on the validity and reliability of MMT reported ICC values of up to 0.96 suggesting it is a reasonably valid tool to assess muscle strength The assessment will be made at baseline, fourth and eighth week

  8th week

Secondary Outcomes (1)

• Berg Balance Scale

  8th week

Study Arms (2)

Group A

EXPERIMENTAL

receive Anodal TDCS with spongy electrodes applied to the M1 (supplementary motor area) of the skull which corresponds to C3 and C4 on the 10/20 EEG system. The intensity of TDCS will be 2.5 mA and the duration will be 20 mints. The intervention will be applied twice a day with a time difference of 30 minutes between the two sessions.

Other: Transcranial Direct Current Stimulation

Group B

SHAM COMPARATOR

receive conventional treatment in the form of motor relearning program (MRP). And Sham application of anodal TDCS

Other: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation OTHER

The intensity of TDCS will be 2.5 mA and the duration will be 20 mints. The intervention will be applied twice a day with a time difference of 30 minutes between the two sessions.

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• Subacute and first MCA stroke
• Ischemic stroke
• Medium to high fall risk on BBS (BBS score ≤ 40)

You may not qualify if:

• Hearing and Visual loss/deficit
• Recurrent CVA
• Neurological condition affecting balance like Multiple Sclerosis, Parkinson disease etc
• Wound at skull
• Presence of shunt and/or metallic implant at cranial region
• Brain tumors
• Musculoskeletal conditions affecting lower limbs
• Cognitively compromised

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rafsan Rehabilitation Center

Peshawar, KPK, Pakistan

Location

Related Publications (3)

• Saini V, Guada L, Yavagal DR. Global Epidemiology of Stroke and Access to Acute Ischemic Stroke Interventions. Neurology. 2021 Nov 16;97(20 Suppl 2):S6-S16. doi: 10.1212/WNL.0000000000012781.

  PMID: 34785599 BACKGROUND

• Dong K, Meng S, Guo Z, Zhang R, Xu P, Yuan E, Lian T. The Effects of Transcranial Direct Current Stimulation on Balance and Gait in Stroke Patients: A Systematic Review and Meta-Analysis. Front Neurol. 2021 May 25;12:650925. doi: 10.3389/fneur.2021.650925. eCollection 2021.

  PMID: 34113308 BACKGROUND

• Li Y, Fan J, Yang J, He C, Li S. Effects of transcranial direct current stimulation on walking ability after stroke: A systematic review and meta-analysis. Restor Neurol Neurosci. 2018;36(1):59-71. doi: 10.3233/RNN-170770.

  PMID: 29439362 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 26, 2023
• Study Start: May 20, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)