Electrical brain stimulation along with physical therapy effect on improving function in patientswith sub-acute stroke

Phase 1/2

Not yet recruiting

Conditions: Cerebral infarction, unspecified,

Registration Number: CTRI/2019/09/021270

Lead Sponsor: King Khalid University

Brief Summary: Background and study aim: Stroke is the foremost cause of death and disability throughout the world. Combining the neuromodulation capability of Transcranial Direct Current Stimulation (tDCS) with a strong clinical treatment tool like Proprioceptive Neuromuscular Facilitation (PNF) could make excellent improvements in the lives of stroke population. tDCS is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain. A constant, low-intensity current is passed through two electrodes placed over the head which modulates brain cell activity. PNF stretching is an advanced form of flexibility training. It involves the contraction and stretching of muscles. Currently, there is dearth of literature pertaining to this combination of tDCS with PNF in improving function and quality of life in subjects with subacute stroke.

The aim of this study is to find the effect of tDCS combined with trunk targeted PNF on impairments, activity limitations and participation restrictions of subjects with sub-acute stroke

Who can participate? Stroke patients aged between 18-75 years who meet the inclusion criteria

What does the study involve? The participants undergo some evaluations, tDCS, and physical exercise treatments over a six week period.

What are the possible benefits and risks of participating? There is a possibility that the patient functional capacity will improve and there is no critical risk of participating in the study Some subjects can feel some fatigue after the exercise

Where is the study run from? King Khalid University, Saudi Arabia

When is the study starting and how long is it expected to run for? May 2019 to May 2020

Who is funding the study? Investigator-initiated and funded

Who is the main contact? Dr. Jaya Shanker Tedla jtedla@kku.edu.sa

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 54

Inclusion Criteria

Age range 18-75 years 2.
First-time supratentorial stroke diagnosed by MRI/CT scan 3.
Between 7 days to 6 months post-stroke 4.
Able to understand and follow the commands.

Exclusion Criteria

Any metals in the cranium/ cochlear implants/ cardiac pacemakers 2.
Having an unstable epileptic disorder 3.
Associated comorbid diseases like cancer/ HIV/Hepatitis or any other neuromuscular disorders which affect the subjects capability to do exercise.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Trunk impairment scale measures trunk activity and measured as a clinical test 2. Fugl-Meyer Assessment of Motor Recovery after stroke (FMA) measures upper and lower limb activity and measured as a clinical test 3. 10 Meter Walk Test (10mWT) measures gait speed and measured as a clinical test 4. Timed up and go test measures balance and gait activity	Baseline and after 6 weeks
5. Wolf Motor Function Test measures upper limb activity and measured as a clinical test	Baseline and after 6 weeks
6. Stroke Specific Quality of life	Baseline and after 6 weeks

Secondary Outcome Measures

Name	Time	Method
1. Age 2. Gender 3. Stroke Onset 4. Type of Stroke 5. Severity of Stroke 6. Type of Treatme	These secondary outcomes required only for doing correlations they are obtained on week one.

Trial Locations

Locations (1): Krishna Institute of Medical Sciences
🇮🇳
Hyderabad, TELANGANA, India
Krishna Institute of Medical Sciences
🇮🇳Hyderabad, TELANGANA, India
Dr Jaya Shanker Tedla
Principal investigator
7674897379
jtedla@kku.edu.sa