Spastic Cerebral PalsyNCT06407856
Dual Task Training in Spastic Cerebral Palsy
A study testing conventional therapy and Dual Task Training in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- conventional therapy and Dual Task Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant's age will be between 6-12 years.
- Patient should be diagnosed with spastic diplegic cerebral palsy.
- GMFCS I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- conventional therapy, Dual Task Training
- Keywords
- cerebral palsy, Dual-Task Training, Gait,, Balance, Cognitive-motor interference
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional therapyOther
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
Dual Task TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| conventional therapy | Experimental | This group will only receive conventional physical therapy. Receives: Other: conventional therapy |
| Dual Task Training with Conventional Therapy | Experimental | This group will only receive Dual Task Training along conventional therapy Receives: Other: conventional therapy; Other: Dual Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale
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
Measured: baseline and 8 weeks
Gait Outcome Assessment List-(GOAL)
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
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 May 2024
- Primary completion5 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tayyaba Khalid, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407856
- Sponsor's protocol ID
- REC/RCR&AHS/23/0774
- Status last verified
- Mar 2025
- First submitted
- 6 May 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20833198Woollacott 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.
PubMed 12127181Manicolo 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.
PubMed 28154547Carcreff 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.
PubMed 30875601Kim 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.
PubMed 24567664
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual Task Training on Balance and Gait in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06407856
- Acronym / sponsor ID
- REC/RCR&AHS/23/0774
- Conditions
- Spastic Cerebral Palsy
- Keywords
- cerebral palsy, Dual-Task Training, Gait,, Balance, Cognitive-motor interference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional therapy | Experimental | Other: conventional therapyThis group will only receive conventional physical therapy. |
| Dual Task Training with Conventional Therapy | Experimental | Other: conventional therapy, Other: Dual Task TrainingThis group will only receive Dual Task Training along conventional therapy |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participant's age will be between 6-12 years.
- Patient should be diagnosed with spastic diplegic cerebral palsy.
- GMFCS I-III
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional therapyThe 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 | Other | Dual Task Training with Conventional Therapy, conventional therapy |
| Dual Task TrainingWarming 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 | Other | Dual Task Training with Conventional Therapy |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 20833198Al-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.
- Background: PubMed 12127181Woollacott 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.
- Background: PubMed 28154547Manicolo 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.
- Background: PubMed 30875601Carcreff 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.
- Background: PubMed 24567664Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tayyaba Khalid, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional therapy and Dual Task Training in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Balance Scale (time frame: baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407856, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.