Anodal TDCS and Postural Stability in Subacute Stroke

Stroke Clinical Trial

Official title:

Effects of Anodal Transcranial Direct Current Stimulation on Postural Stability in Sub-Acute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05903599
• Other study ID #: REC01353 Somia Shakeb
• Status: Completed
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Pakistan	Pakistan Railway General Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Timed Up and Go Test (TUG)	TUG test is a general performance test used to assess mobility, balance and locomotor performance in patients with balance disturbances. The patients are asked to stand up from chair, walk to a line of 3 meters length at a normal pace, turn and walk back to the chair at your normal pace and sit down. A patient whose score is less than 10 seconds is characterized as completely independent. Assessment time will be at 0, 3rd, 6th,9th,12th week	12th week
Secondary	Functional Reach Test (FRT)	a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. The patient is instructed to stand next to but not touching a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the third metacarpal head on the yardstick. Instruct the patient to reach as far as you can forward without taking a step. The location of the third metacarpal is recorded. Scores are determined by assessing the difference between the start and end positions in the reach distance usually measured in inches. Three trials should be done and the average of the last two is noted. Assessment time will be at 0, 3rd, 6th,9th,12th week	12th week
Secondary	Stroke Specific Quality of life Scale (SS-QoL)	a reliable and valid tool for measuring self-reported health -related quality of life. It is a patient centered outcome measure intended to provide an assessment of health-related quality of life specific with stroke. Scale domains and items were derived from series of interviews with post stroke patients. They must respond to each question of the SS-QOL with reference to the past week. It contains 49 items in 12 domains: mobility, energy, upper extremity function (5 items), work/productivity (3 items ), mood (5 items), social roles (5 items),family roles (3 items ), language (5 items ), thinking (3 items), personality (3 items) higher scores indicate better functioning. Assessment time will be at 0, 3rd, 6th,9th,12th week	12th week