NCT06905457

Brief Summary

Background: Stroke is clinical defined as a neurological syndrome characterized by acute disruption of blood flow to an area of brain and corresponding onset of neurological defects related to the concerned area of brain. Hemiplegic patient primarily affects the upper limb and lower limb of one side and typically results in flaccidity and difficulties with motor control and function.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Start

First participant enrolled

March 20, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 25, 2025

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment scale(FMA)

    The total possible scale score is 226. Points are divided among the domains as follows: Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.

    12 Months

  • Modified ashworth scale( MAS)

    The Modified Ashworth Scale (MAS) is a clinical tool used to measure spasticity, a velocity-dependent increase in muscle stretch reflexes, by assessing the resistance to passive movement. It's a six-level ordinal scale, ranging from 0 (no increase in tone) to 4 (affected part rigid)

    12 Months

Study Arms (2)

Vojta therapy

EXPERIMENTAL
Combination Product: Vojta therapy

Bobath therapy

EXPERIMENTAL
Combination Product: Bobath therapy

Interventions

Vojta therapyCOMBINATION_PRODUCT

Vojta therapy, also known as Reflex Locomotion Therapy, is a specialized physiotherapy technique developed by Czech neurologist Václav Vojta, using sensory stimulation to activate innate movement patterns and improve motor skills, posture, and overall function

Vojta therapy
Bobath therapyCOMBINATION_PRODUCT

Bobath therapy, also known as Neurodevelopmental Treatment (NDT), is a problem-solving approach to neurological rehabilitation, focusing on motor learning and efficient motor control to improve function and participation in daily activities

Bobath therapy

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Hemiparetic stroke.
  • adult's stroke (1-4 months post- onset)
  • Ability to follow instructions and participate in testing
  • Aged 25-75 years.

You may not qualify if:

  • Previous history of brain surgery.
  • Pregnant women.
  • Limitation in cognitive skills like Aphasia, deteriorated consciousness or dementia.
  • Severe cardiovascular disease (unstable hypertension)"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aqsa physiotherapy clinic, Main Sheikhupura road near Sitara Velly

Faisalābad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 1, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations