- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484581
Effect of Wobble Board Exercises Versus Swiss Ball Exercises on Balance and Functional Stability of Stroke Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Wobble Board Exercises
Exercises:
|
Duration: 10 minutes per session Frequency: 3 sessions per week Objective: Establish foundational balance in standing for mild-to-moderate spasticity levels. Exercises:
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:
|
|
Experimental: Swiss Ball Exercises
Seated Balance: Sitting on Swiss ball to activate the core without overstressing spastic or weak muscles.
|
Duration: 10 minutes per session Frequency: 3 sessions per week Objective: Build initial seated balance and core activation on the Swiss ball. Exercises:
Exercises:
Duration: 30 minutes per session |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
(FSST) Four-Square Step Test
Time Frame: 2 to 4 mins
|
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)
Time Frame: 2 to 4 mins
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sobia Kanwal, tDPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S24C14G37001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
Clinical Trials on Wobble Board Exercises
-
Steadman Philippon Research InstituteNational Institute on Aging (NIA); Neuromuscular DynamicsRecruitingOsteo Arthritis of the KneeUnited States
-
Riphah International UniversityRecruitingElderly PopulationPakistan
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
Badr UniversityEnrolling by invitation
-
Cairo UniversityCompletedDiplegic Cerebral Palsy | Balance Board | Standing BalanceEgypt
-
Geisinger ClinicCompletedRadiation Exposure to OperatorUnited States
-
University of MinnesotaWithdrawnMal de Debarquement Syndrome
-
Ontario Clinical Oncology Group (OCOG)U.S. Army Medical Research and Development Command; Supportive Cancer Care...Completed
-
Dana-Farber Cancer InstituteBrigham and Women's HospitalCompleted
-
Louise FarrerWithdrawn