NCT07484581

Brief Summary

A stroke is characterized as a condition in which the brain's main arteries get clogged, reducing oxygen flow and potentially leading to death or severe disability. There are various types of strokes, such as transient ischemic attack (TIA), hemorrhagic stroke, and ischemic stroke. Hemorrhagic stroke is the most prevalent kind among them Strokes frequently alter postural balance. Balance is a complicated process that involves both static and dynamic elements. It significantly influences gait performance and community ambulation after strokes. Balance impairment is a common cause of falls in stroke survivors. Post-stroke recovery is related to loss of control of one's body posture, uneven weight distribution, and lack of anticipatory and reactive balance, which hinder movement in the community and severely affect one's quality of life. The loss of balance is one of the major problems that stroke patients have to deal with and is considered the most serious part of the illness. Medically, it is characterized as the result of multiple factors such as: i) damage to brain areas responsible for processing vestibular input, ii) blockage for proprioceptive feedback, iii) poor coordination among the different brain regions involved in motor planning and execution and visual feedback. These factors, in turn, and together, block the person's body from moving stably during static and dynamic activities. More than 70% of stroke patients develop significant balance problems within the first year of the stroke and such problems, besides other factors, are the reason for the high occurrence of falls among them. Reports indicate that the fall rate in the stroke population is more than double that in the non-disabled elderly.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable stroke

Status
not yet 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 Progress46%
Feb 2026Aug 2026

Study Start

First participant enrolled

February 28, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 16, 2026

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • (FSST) Four-Square Step Test

    The Four-Square Step Test (FSST) is a dynamic evaluation tool for balance and coordination in which participants step forward, sideways, and backward over four canes set in a cross pattern. Score is determined by the time that it takes to finish; two trials are made, and the best time is noted. Research has confirmed its reproducibility and validity, such as musculoskeletal problems, neurological illnesses, and elderly adults. With a cut-off period of 15 seconds, it accurately detects fall risk, with older persons having a larger chance of falling

    2 to 4 mins

  • Berg Balance Scale (BBS)

    An instrument that is frequently used to evaluate an adult's balance and fall risk is the Berg Balance Scale (BBS). It has 14 tasks with a maximum score of 56, and each activity is rated on a scale of 0 to 4. Improved balance is indicated by higher scores. Low fall risk is indicated by scores 41-56, medium fall risk by scores 21-40, and high fall risk by scores 0-20. Particularly in stroke rehabilitation, it predicts functional results and correlates well with other balance measures

    2 to 4 mins

Study Arms (2)

Wobble Board Exercises

ACTIVE COMPARATOR

Exercises: * Static Standing: Participants stand on the wobble board with assistance as needed to develop balance without causing undue strain on spastic muscles. * Gentle Weight Shifts: Controlled side-to-side and front-to-back shifts (10-15 repetitions) for proprioception and core activation, adjusted to individual spasticity levels. * Static Balance Drills: Standing on the wobble board with increasing independence, focusing on postural alignment and balance. * Heel-to-Toe Walking: Slow, controlled steps (10 repetitions) on a stable surface to promote coordination and foot placement control. * Controlled Weight Shifts:

Other: Wobble Board Exercises

Swiss Ball Exercises

EXPERIMENTAL

Seated Balance: Sitting on Swiss ball to activate the core without overstressing spastic or weak muscles. * Gentle Bouncing: Slow, controlled bounces (10-15 repetitions) to improve dynamic seated stability within a safe range for those with mild to moderate spasticity Single-Leg Balance (Assisted): Alternating seated balance on one leg (10-15 repetitions each leg), ensuring safety for spasticity concerns. * Bridges: Controlled bridging to improve core and glute strength without stressing lower limb spasticity. * Side Bends: Slow side bends (10-15 repetitions per side) to activate lateral stabilizers without excess strain.

Other: Swiss Ball Exercises

Interventions

Duration: 10 minutes per session Frequency: 3 sessions per week Objective: Establish foundational balance in standing for mild-to-moderate spasticity levels. Exercises: * Static Standing: Participants stand on the wobble board with assistance as needed to develop balance without causing undue strain on spastic muscles. * Gentle Weight Shifts: Controlled side-to-side and front-to-back shifts (10-15 repetitions) for proprioception and core activation, adjusted to individual spasticity levels. Duration: 25 minutes per session Frequency: 3 sessions per week Objective: Gradual increase in static balance exercises to enhance postural control without exceeding tolerance levels. Exercises: * Static Balance Drills: Standing on the wobble board with increasing independence, focusing on postural alignment and balance. * Heel-to-Toe Walking: Slow, controlled steps (10 repetitions) on a stable surface to promote coordination and foot placement control. * Controlled Weight Shifts:

Wobble Board Exercises

Duration: 10 minutes per session Frequency: 3 sessions per week Objective: Build initial seated balance and core activation on the Swiss ball. Exercises: * Seated Balance: Sitting on Swiss ball to activate the core without overstressing spastic or weak muscles. * Gentle Bouncing: Slow, controlled bounces (10-15 repetitions) to improve dynamic seated stability within a safe range for those with mild to moderate spasticity Duration: 25 minutes per session Frequency: 3 sessions per week Objective: Increase core stability and seated balance while avoiding excessive muscle fatigue. Exercises: * Seated Balance Drills: Static seated balance drills to reinforce postural control. * Pelvic Tilts: Gentle, slow tilts (10 repetitions per side) to engage core stabilizers without excessive hip muscle strain. * Simple Reaches: Reaching exercises (10 repetitions per direction) that challenge seated stability in a controlled range of motion. Duration: 30 minutes per session

Swiss Ball Exercises

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants were required to have a history of stroke (\>6-months)
  • Age; 40-60 years old both male and female.
  • Patients who have Ischemic or Hemorrhagic stroke
  • Participants must tolerate at least 30 minutes of seated or standing activity to participate in the program progressively.
  • Participants must have intact or corrected eyesight in order to use the equipment and visual balancing cues properly.
  • The participant should be able to stand with little assistance and sit on their own.

You may not qualify if:

  • Subjects with impaired visual or vestibular impairment and systemic illness
  • Subjects unable to provide a proper medical history
  • Subjects with neuropathies due to non-diabetic cause
  • Subjects with any other neurological condition that can impair balance
  • Subjects with any other musculoskeletal conditions that cause pain and instability
  • Subjects with severe diabetes with foot ulcers or foot deformities
  • Subjects with any kind of lower limb amputation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sobia Kanwal, tDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 20, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share