Effect of brain stimulation along with gait training in improving life participation among hemiplegia patients

ISRCTN	ISRCTN62197971
DOI	https://doi.org/10.1186/ISRCTN62197971

Submission date: 26/12/2024
Registration date: 12/01/2025
Last edited: 08/01/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The subacute phase of stroke is critical for rehabilitation, yet many patients continue to experience substantial disabilities and decreased quality of life. Rehabilitation approaches like gait training or neuromodulation treatments result in significant improvements. However, combining neuromodulation with a physical activity intervention had more significant results in recent studies. Hence this study aimed to find out whether gait-oriented therapy augmented by transcranial direct current stimulation (tDCS) promotes functional recovery of neurological and muscular impairments.

Who can participate?
Subacute stroke patients aged 18–80 years

What does the study involve?
Participants were randomly allocated to one of two groups. The study experimental group was given tDCS (2 mA, 20 minutes, 3 days per week for 4 weeks) along with gait-oriented motor training, while the control group received motor training alone.

What are the possible benefits and risks of participating?
The possible benefits were improved function, balance, gait, and quality of life, and there were no risks for the participants.

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?
August 2023 to May 2024

Who is funding the study?
King Salman Center for Disability Research (Saudi Arabia)

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

Contact information

Dr Jaya Shanker Tedla
Public, Scientific, Principal Investigator

S-058, Building Number M03
College of Applied Medical Sciences
King Khalid University
Al Fara
Abha
61421
Saudi Arabia

ORCID ID	0000-0002-2876-4227
Phone	+966 (0)538901083
Email	jtedla@kku.edu.sa

Study information

Study design	Interventional single-blinded randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	University/medical school/dental school
Study type	Quality of life, Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Effects of transcranial direct current stimulation combined with gait-oriented motor training on disability, quality of life, and motor functions in individuals with sub-acute stroke: a randomized controlled trial
Study acronym	tDCSGOMT
Study objectives	This research will contribute to advancing the understanding and use of combined neuromodulation and motor training methods in stroke rehabilitation.
Ethics approval(s)	Approved 19/12/2023, Institutional Review Board of the Deanship of Scientific Research, King Khalid University (Deanship of Scientific Research, King Khalid University, Abha, 61421, Saudi Arabia; +966 (0)17 2418645; ecm@kku.edu.sa), ref: ECM#2023-3304
Health condition(s) or problem(s) studied	Sub acute stroke
Intervention	A curated protocol with tDCS and gait-oriented motor training was applied to the intervention group. The control group received only gait-oriented motor training. To ensure equal distribution of the groups in the study, a computer-generated block random allocation sequence was used. To maximize protocol compliance, both groups were supervised by trained rehabilitation therapists. In both groups, sessions were held for 1 hour, 3 days a week for 4 weeks.
Intervention type	Other
Primary outcome measure	Measured before the beginning of the study intervention, after 4 weeks of the study intervention, and after 3 months of post-intervention: 1. Disability measured with the World Health Organization Disability Assessment Schedule 2. Quality of life assessed with the Stroke Impact Scale
Secondary outcome measures	Measured before the beginning of the study intervention, after 4 weeks of the study intervention, and after 3 months of post-intervention: 1. Motor function measured with the Fugl-Meyer Assessment for Lower Extremities 2. Balance evaluated by the Berg Balance Scale 3. Functional mobility was assessed by the Timed Up and Go test
Overall study start date	15/08/2023
Completion date	31/05/2024

Eligibility

Participant type(s)	Patient
Age group	Senior
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	62
Total final enrolment	62
Key inclusion criteria	1. Medically stable adults aged 18–80 years 2. Experienced a first-ever ischemic or hemorrhagic stroke 3. Reduced motor control in the lower extremities 4. Mini-Mental State Examination for cognitive function score ≥24
Key exclusion criteria	1. Presence of severe spasticity (Modified Ashworth Scale score >3) 2. Currently participating in another rehabilitation program 3. Significant comorbidities that might cause exclusion from participation (severe cardiovascular disease or orthopedic conditions) 4. tDCS contraindications such as implanted electronic devices or a history of epilepsy
Date of first enrolment	01/01/2024
Date of final enrolment	01/05/2024

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

Program of Physical Therapy, Department of Medical Rehabilitation Sciences

Building Number W4
College of Applied Medical Sciences
King Khalid University
Al Fara
Abha
61421
Saudi Arabia

Sponsor information

King Salman Center for Disability Research
Research organisation

Embassy Area
Riyadh
11614
Saudi Arabia

Phone	+966 (11) 4884401
Email	RG-Inquiry@kscdr.org.sa
Website	https://www.kscdr.org.sa/en
"ROR"	https://ror.org/01ht2b307

Funders

Funder type

Research organisation

King Salman Center for Disability Research
Private sector organisation / Research institutes and centers

Alternative name(s): مركز الملك سلمان لأبحاث الإعاقة, KSCDR
Location: Saudi Arabia

Results and Publications

Intention to publish date	01/05/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	Planned publication in a peer-reviewed international journal
IPD sharing plan	The datasets generated and/or analysed during the current study will be published as a supplement to the results publication

Editorial Notes

08/01/2025: Study's existence confirmed by the Research Ethics Committee at King Khalid University.