Anodal Transcranial Direct Current Stimulation on Strength in Subacute Stroke

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT05878626
• Lead Sponsor: Riphah International University

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

Detailed Description

Transcranial direct current stimulation (TDCS) is a relatively new treatment approach for stroke recovery. TDCS is a neuromodulation method which involves application of weak direct current stimulations over the scalp via electrodes. It could induce plasticity via modulation of resting membrane potential and modification of spontaneous discharge rate.

TDCS has been shown to have beneficial effects on mobility, muscle strength, motor learning, lower limb function, balance, gait, functionality and walking ability in post stroke patients. TDCS appears to be a promising intervention for stroke patients however its effects are not significant if used in isolation. Thus, it should be used as an adjunct to some other treatment.

Review of available literature indicates TDCS can be a good option in short and intermediate run but its effects in the long run have not been studied yet. Furthermore, to the best of my knowledge there is little literature available about the long-term effects of TDCS on muscle strength in subacute stage. Therefore, this study is designed to test the long-term effects of TDCS stimulation on subacute stroke patients.

Study Timeline

• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-18
• Study Start: 2023-05-20
• Study First Posted: 2023-05-26
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Manual muscle testing	8th week	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

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	8th week	BBS is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five point scale ranging from 0 to 4, 0 indicating the lowest level of function and 4 indicating the highest level of function. The maximum score is 56 indicating normal function. A score of 41 to 56 indicates mild risk fall, 21 to 40 indicates medium risk fall and 0 to 20 indicates high risk fall. A study on various scales used for assessing balance and function has reported ICC values of 0.99 The assessment will be made at baseline, fourth and eighth week.

Trial Locations

Locations (1)

Rafsan Rehabilitation Center; 🇵🇰 Peshawar, KPK, Pakistan