- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407856
Dual Task Training in Spastic Cerebral Palsy
March 10, 2025 updated by: Riphah International University
Effects of Dual Task Training on Balance and Gait in Children With Spastic Cerebral Palsy
Cerebral palsy(CP) is a non-progressive disorder, undergoing mishap to the developing brain and it affect a person's ability to move and maintain balance and posture.
Old name of CP is "Little's disease".
In Spastic diplegic, muscle stiffness is mainly in the legs, with the arms less affected or not affected at all.
There could be secondary musculoskeletal problems due to muscle weakness resulting from poor alignment, limited range of motion, and asymmetrical posture.
These deformities are negatively affected by biomechanical movements and can affect balance and gait functions.
The main goal of rehabilitation in children with cerebral palsy is to restore independent walking.
However, children with cerebral palsy have limited mobility, which leads to gait disorders (short steps, slow walking speed, increased swing phase and postural instability).
Therefore, it is important to choose an effective training method to improve the balance and gait of children with cerebral palsy.
Walking training can help improve muscle tone, postural control and gait function as well as improve muscle strength, endurance, and coordination of the lower extremities.
A growing body of evidence supports implementing dual-task gait training for enhancing functional mobility and cognitive performance.
This will be a randomized controlled trial, data will be collected from Rising Sun Institute, Mughalpura campus.
A study will be conducted on 32 patients.
Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 to 3 and those who can walk 50 m without mechanical walking aids and maintain standing for more than 5 seconds without falling will be included.
Exclusion criteria of this study is low intellectual ability (IQ < 80) and behavioral symptoms which might affect participation in the protocol, none of the children had surgery or botulinum toxin injections during the year prior to the assessment.
Group1 will receive conventional therapy for 30 minutes a day, 3 times a week for 8 weeks.
And group 2 will receive conventional therapy with dual-task training for 30 minutes a day, 3 times a week for 8 weeks.
For the pre- and post-evaluation of all participants Berg balance scale and Gait outcome assessment list-(GOAL) will be used.
Data will be analyzed through SPSS version 23.00.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Imran Amjad
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participant's age will be between 6-12 years.
- Patient should be diagnosed with spastic diplegic cerebral palsy.
- GMFCS I-III
Exclusion Criteria:
- Low intellectual ability (IQ < 80) and behavioral symptoms which might affect participation in the protocol.
- If patient had any progressive neurological disorder disease.
- If he/she had surgery or botulinum toxin injections during the year prior to the assessment will also be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: conventional therapy
This group will only receive conventional physical therapy.
|
The control group embarked on a conventional therapy regimen designed for patients with spastic diplegic cerebral palsy.
This group will do 10reps of ROM exercises, 3 times stretching 30sec hold with 10sec rest and 5reps of strengthening exercises, standing , weight on one leg and raising the other leg to the side or behind, putting heel in front of your toe i.e., tandem stance, standing up and sitting down from a chair without using hands, walking while alternating knee lifts with each step.This group will do conventional therapy for 30 minutes a day, 3 times a week for 8 weeks
|
|
Experimental: Dual Task Training with Conventional Therapy
This group will only receive Dual Task Training along conventional therapy
|
The control group embarked on a conventional therapy regimen designed for patients with spastic diplegic cerebral palsy.
This group will do 10reps of ROM exercises, 3 times stretching 30sec hold with 10sec rest and 5reps of strengthening exercises, standing , weight on one leg and raising the other leg to the side or behind, putting heel in front of your toe i.e., tandem stance, standing up and sitting down from a chair without using hands, walking while alternating knee lifts with each step.This group will do conventional therapy for 30 minutes a day, 3 times a week for 8 weeks
Warming up exercise Supine Trunk and lower extremity ROM exercise Main exercise Sitting Base of support: balance cushion, ball Program: perform cognition task while maintaining balance (writing, drawing, puzzle etc.) Bench sitting (half ring P.) Base of support: balance pad Program: perform fine motor activities while maintaining balance (blocks assembly, scissoring, origami etc.) Standing Base of support: balance pad, balance cushion Program: perform eating while maintaining balance (drinking water, eat a snack etc.) Cool down exercise Supine Low extremity stretching & deep breathing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Balance Scale
Time Frame: baseline and 8 weeks
|
The (PBS) pediatric balance scale, a modification of the Berg Balance Scale, was developed as a balance measure for school-age children with mild-to-moderate motor impairments.
It gives good test-retest and interrater reliability when used, ranged from 0.87 to 1.0
|
baseline and 8 weeks
|
|
Gait Outcome Assessment List-(GOAL)
Time Frame: baseline and 8 weeks
|
Gait Outcome Assessment List-(GOAL) is a valid assessment of gait function in ambulant children with CP.
It has the potential to improve understanding of the child's and parents' priorities and thus, in conjunction with IGA, provide a more balanced assessment across the domains of theorld Health Organization's International Classification of Functioning, Disability and Health.
It is a valid and reliable tool.
It has a reliability of 0.92 and validity of 0.90
|
baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tayyaba Khalid, MS*, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kim GY, Han MR, Lee HG. Effect of Dual-task Rehabilitative Training on Cognitive and Motor Function of Stroke Patients. J Phys Ther Sci. 2014 Jan;26(1):1-6. doi: 10.1589/jpts.26.1. Epub 2014 Feb 6.
- Woollacott M, Shumway-Cook A. Attention and the control of posture and gait: a review of an emerging area of research. Gait Posture. 2002 Aug;16(1):1-14. doi: 10.1016/s0966-6362(01)00156-4.
- Al-Yahya E, Dawes H, Smith L, Dennis A, Howells K, Cockburn J. Cognitive motor interference while walking: a systematic review and meta-analysis. Neurosci Biobehav Rev. 2011 Jan;35(3):715-28. doi: 10.1016/j.neubiorev.2010.08.008. Epub 2010 Sep 15.
- Manicolo O, Grob A, Hagmann-von Arx P. Gait in Children with Attention-Deficit Hyperactivity Disorder in a Dual-Task Paradigm. Front Psychol. 2017 Jan 19;8:34. doi: 10.3389/fpsyg.2017.00034. eCollection 2017.
- Carcreff L, Fluss J, Allali G, Valenza N, Aminian K, Newman CJ, Armand S. The effects of dual tasks on gait in children with cerebral palsy. Gait Posture. 2019 May;70:148-155. doi: 10.1016/j.gaitpost.2019.02.014. Epub 2019 Feb 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2024
Primary Completion (Actual)
August 5, 2024
Study Completion (Actual)
August 15, 2024
Study Registration Dates
First Submitted
May 6, 2024
First Submitted That Met QC Criteria
May 6, 2024
First Posted (Actual)
May 9, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 10, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0774
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Spastic Cerebral Palsy
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Beni-Suef UniversityNot yet recruitingUnilateral Spastic Cerebral Palsy
-
Cairo UniversityActive, not recruitingCerebral Palsy Spastic HemiplegicEgypt
-
Cairo UniversityCompletedCerebral Palsy Spastic HemiplegicEgypt
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Wroclaw University of Health and Sport SciencesNot yet recruitingSpastic Diplegia Cerebral Palsy | Spastic HemiplegiaPoland
-
TC Erciyes UniversityEnrolling by invitationCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyTurkey
-
University of LahoreCompletedCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Balance | Gross Motor FunctionsPakistan
Clinical Trials on conventional therapy
-
Istanbul Medipol University HospitalActive, not recruiting
-
Mennallah Ahmed Mohamed Anwar ElgendyNot yet recruiting
-
Riphah International UniversityCompletedChildren, AdultPakistan
-
Elite College of Management Sciences, Gujranwala...Completed
-
Beijing Tiantan HospitalXiangya Hospital of Central South University; Zhongnan HospitalRecruitingPain | Herpes Zoster | Postherpetic NeuralgiaChina
-
Universidad de CórdobaActive, not recruiting
-
Istanbul Medipol University HospitalCompleted
-
Beijing Tiantan HospitalRecruitingPain | Herpes ZosterChina
-
Riphah International UniversityRecruitingHyperkypohsis and Impaired Lung FunctionPakistan
-
Riphah International UniversityCompleted