NCT06882213

Brief Summary

To evaluate the effects of the combining transcranial direct current stimulation with core stability exercises on trunk performance in poststroke hemiparetic patients, the secondary outcome is to evaluate the balance and the functional performance of the participants.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
0mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Mar 2025Jun 2026

First Submitted

Initial submission to the registry

March 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

March 29, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 17, 2026

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

March 12, 2025

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Trunk Impairment Scale (TIS).

    trunk performance will be assessed by Trunk Impairment Scale (TIS).

    up to 8 weeks

  • Berg Balance Scale

    Balance will be assessed by berg balance scale, the balance score ranges from 0 to 56, with lower scores indicating increased risk of balance loss and higher scores indicating improved functional mobility. Time up and go test (TUG)n Score \< 10 seconds = normal \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid

    up to 8 weeks

Study Arms (2)

Study Group

ACTIVE COMPARATOR

will receive simultaneously a combination of transcranial direct current stimulation combined with core stability exercise.

Other: transcranial direct current stimulationOther: core stability exercise.

Control group

ACTIVE COMPARATOR

will receive core stability exercise.

Other: core stability exercise.

Interventions

transcranial direct current stimulation

Study Group

core stability exercise.

Control groupStudy Group

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will be included if they are ≥ 55 years old of both sex, had a first-time right or left stroke within the preceding six months that damaged the cerebral cortex verified by (computed tomography or MRI report, neurological examination, and medical chart).
  • Patients can stand and walk independently.
  • Modified Ashworth Scale (MAS) of upper limb muscle ≤ 1+.
  • All the patients received a conventional physiotherapy program in the acute stage and post-discharge from the hospital.
  • None of the patients participated in any other study or placebo

You may not qualify if:

  • Patients with neurological or orthopedic problems, paralysis neglect, behavioral abnormalities, dementia any shoulder dysfunction before or post-stroke (dislocation or subluxation), or those who using upper limb splints.
  • Recurrent strokes or hemiparesis due to other neurological causes rather than stroke eg .(Brain tumor).
  • Obesity (BMI ≥ 30 kg/m2).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni suef hospital

Banī Suwayf, 62511, Egypt

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical therapy

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 18, 2025

Study Start

March 29, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 17, 2026

Record last verified: 2025-03

Locations