Focal Muscle Vibration and tDCS on Motor Recovery in Stroke

NCT06893653 | Recruiting

• 1 other identifier: MalihaREC02168
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Although tDCS and FV have shown some benefit as stand-alone treatment, researcher suggest that combining intervention with complementary mechanism can lead to additive or synergistic benefits which might yield more significant improvement in functional outcome hence the author propose to plan the combination of FV with tDCS for motor recovery /spasticity in stroke patients.

Conditions

Stroke

Keywords

stroke; tDCS; motor activity; spasticity

Outcome Measures

Primary Outcomes (2)

• Fugl Meyr Assessment

  FMA is used for the assessment of physical performance and sensorimotor function of neurological patients. It uses a 3-point ordinal scale to score individuals' ability to perform a certain task. Total score is 226. It has excellent inter and intrarater reliability

  20th week

• Modified Ashworth Scale

  MAS is a tool to measure hypertonia. It scores the resistance on a 5 point ordinal scale with an increase value indicating hypertonia. Intrarater reliability of MAS was found to be good to excellent for upper (k= 0.71-0.94) and lower extremities(k= 0.55-0.97) while interrater reliability was poor to moderate for upper (k= 0.25-0.66) and lower extremities

  20th week

Secondary Outcomes (1)

• Stroke Specific Quality of Life questionnaire

  20th week

Study Arms (4)

FMV

ACTIVE COMPARATOR

FMV + PT

Device: Focal muscle vibration; Other: Physical Therapy

tDCS

ACTIVE COMPARATOR

tDCS + PT

Device: tDCS; Other: Physical Therapy

FMV & tDCS

ACTIVE COMPARATOR

FMV + tDCS + PT

Other: Physical Therapy; Device: Focal muscle vibration & tDCS

PT

ACTIVE COMPARATOR

PT only

Other: Physical Therapy

Interventions

Focal muscle vibration DEVICE

FMV will be applied to the muscle belly along with the conventional physical therapy

FMV

tDCS DEVICE

tDCS will be applied to M1 area of brain along with the conventional physical therapy

tDCS

Physical Therapy OTHER

Conventional physical therapy will be provided

FMV; FMV & tDCS; PT; tDCS

Focal muscle vibration & tDCS DEVICE

Focal muscle vibration with tDCS and conventional physical therapy will be provided.

FMV & tDCS

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic stroke
• Spasticity \> 1 at Modified Ashworth Scale.
• FMA score more than 36

You may not qualify if:

• Metallic implant including shunt, intracranial pacemaker, surgical clip etc.
• Any neurological disorder other than stroke
• Any Orthopedic impairment that limit the motor recovery

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Related Publications (3)

• Chow AD, Shin J, Wang H, Kellawan JM, Pereira HM. Influence of Transcranial Direct Current Stimulation Dosage and Associated Therapy on Motor Recovery Post-stroke: A Systematic Review and Meta-Analysis. Front Aging Neurosci. 2022 Mar 18;14:821915. doi: 10.3389/fnagi.2022.821915. eCollection 2022.

  PMID: 35370603 BACKGROUND

• Wang H, Yu H, Liu M, Xu G, Guo L, Wang C, Sun C. Effects of tDCS on brain functional network of patients after stroke. IEEE Access. 2020 Nov 13;8:205625-34

  BACKGROUND

• Wang H, Chandrashekhar R, Rippetoe J, Ghazi M. Focal muscle vibration for stroke rehabilitation: a review of vibration parameters and protocols. Applied Sciences. 2020 Nov 21;10(22):8270

  BACKGROUND

MeSH Terms

Conditions

Stroke; Motor Activity; Muscle Spasticity

Interventions

Transcranial Direct Current Stimulation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maliha Sayyad, DPT

CONTACT

0092 341 2734811; malihasayyad9@gmail.com

Mirza Obaid Baig, MSPT

CONTACT

00923332238706; obaid.baig@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)