Cerebral PalsyNCT06407765
Effects of Dual Task Training on Balance, Activity and Participation in Children With Cerebral Palsy
A study testing Dual task training and Dual task training with backward walking in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy is a non progressive neurodevelopmental disorder that usually effects the muscles of the patients effecting its tone, strength and eventually ability to move. Dual tasking training incorporates more than one task at a time, it can b either physical task with movement or mental tasks. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Dual task training and Dual task training with backward walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 16 May 2024to 23 Jul 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
- Children with cerebral palsy who have already received a diagnosis
- Children with GMFCS Level I-II
- Children between the ages of 6 and 12
Who cannot join
- Being unable to complete the cognitive task, which involves counting back one after each number between 0 and 100
- Posing a behavioral issue that makes it challenging to engage in the study
- Being unable to walk independently
- Children with concomitant cardiac conditions
- Any musculoskeletal surgery performed during the previous six months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Punjab Province, 540000
About this study
Official title: Effects of Dual Task Training With and Without Backward Walking on Balance, Activity and Participation in Children With Cerebral Palsy
Cerebral palsy is a non progressive neurodevelopmental disorder that usually effects the muscles of the patients effecting its tone, strength and eventually ability to move. Dual tasking training incorporates more than one task at a time, it can b either physical task with movement or mental tasks. Backward walking is used to challenge the proprioception.
The study is a randomized controlled trial to assess the effects of Dual task training with and without Backward walking on balance, activity and participations on children with cerebral palsy. Study will be conducted in PSRD and Rehab care. Sample will be recruited randomly and then divided into two groups control and experimental group. Control group will receive dual task training and experimental group will receive both dual task training and backward walking. This treatment would continue for 4 weeks. Patient will be assessed both at the start and end of 4 weeks. The outcome tools for assessment of balance, activity and participation will be following: Pediatric Berg Balance Scale, Time up and Go test and Participation of daily life PODCI Questionnaire. Ethical consideration will be followed and informed consent will be taken from legal guardians.
Read the detailed description
The randomized control trail includes two groups; Control and experimental group. Control group will receive Dual task training. Dual task training incorporates cognitive and motor task. motor task like waking on balance beam is combined with visual memory tasks like pointing towards an object the therapists asks, ask the patient to collect the hanging stars while different shapes are hanging above him, name the object in the picture shown to patient. This treatment will continue for 4 weeks, 4 times a week for 40 minutes.
Experimental group will receive both Dual task training and Backward walking. with the activities mentioned above patient will be asked to walk backward with any obstacle firstly with complete physiotherapist assistance and then gradually with less assistance. Secondly patients will be asked to cover a distance of 15 m through the treatment room's hallway while holding a safety bar with the hand on the unaffected side. Third, without using a safety bar, the participants were urged to walk freely. Lastly, the participants tried to walk backwards at a reasonable pace while progressively increasing their distance travelled and speed. the duration of the treatment will be the same. The patients will be assessed first at the start of treatment and then at the end of 4 weeks.
- Conditions
- Cerebral Palsy
- Being tested
- Dual task training, Dual task training with backward walking
- Keywords
- Cerebral Palsy, Dual task training, Backward Walking, Activity, Balance
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task trainingOther
Dual task training incorporates both cognitive and motor tasks. Tasks like walking and asking the patient to point towards objects, collect start from the objects hanging above the patient and asking the patient to name the objects shown to him/her. This treatment will be given for 4 weeks, 4 times a week for 40 minutes. Each task is done for 7 minutes with a 3 minutes break in between.
Dual task training with backward walkingOther
This group will get both dual task training and backward walking. For dual task training same protocol as active comparator is followed. For backward walking; the patient is firstly asked to walk backward with complete physiotherapist assistance. Secondly, the patient is asked to walk for 15 m through the treatment room's hallway while holding a safety bar with the hand on the unaffected side. Third, without using a safety bar, the participants were urged to walk freely. Lastly, the participants tried to walk backwards at a reasonable pace while progressively increasing their distance travelled and speed. This treatment will be given for 4 weeks, 4 times a week for 40 minutes. Each task is done for 7 minutes with a 3 minutes break in between.
| Study group | Role | What they receive |
|---|---|---|
| Dual Task Training | Active comparator | This group will receive Dual task training Receives: Other: Dual task training |
| Dual task training with Backward walking | Experimental | This group will receive both Dual task training with Backward walking Receives: Other: Dual task training with backward walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Berg Balance Scale
A version of Berg's Balance Scale, the Pediatrics Balance Scale (PBS) was created as a balancing assessment for school-age children with mild to moderate motor deficits. There is a 0.998 intra-class correlation value (ICC).
Measured: 4 weeks
Time up and go test
In clinical practice, the "timed up and go" (TUG) test is a brief assessment tool used to evaluate adults' functional mobility. The TUG test has a high level of dependability in children as well, with an ICC of 0.99 both within a session and between tests.
Measured: 4 weeks
Participation of Daily Life PODCI Questionnaire
The PODCI is a parent-reported outcome measure that evaluates children's expectations of healthcare interventions as well as their mobility, physical function, comfort, and happiness. When assessing quality of life issues and walking function in children with cerebral palsy, the PODCI shows good validity and reliability.
Measured: 4 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 start16 May 2024
- Primary completion1 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Model description
- It will be a Randomized control trail. Convenient random sampling is used to collect the sample. The population under study is Cerebral palsy children. The study sample group are between the age of 6 to 12. The group is randomly divided into two groups; Control and experimental group. The control group will receive Dual task training. The experimental group will receive both dual task training and backward walking. The patients will be assesed at the start and then after 4 weeks of treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aqsa Butt, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407765
- Sponsor's protocol ID
- REC/RCR&AHS/22/0732
- Status last verified
- Jul 2024
- First submitted
- 6 May 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisher-Pipher S Pt Dpt, Kenyon LK Pt Dpt PhD Pcs, Westman M Pt Dpt. Improving balance, mobility, and dual-task performance in an adolescent with cerebral palsy: A case report. Physiother Theory Pract. 2017 Jul;33(7):586-595. doi: 10.1080/09593985.2017.1323359. Epub 2017 May 16.
PubMed 28509631Butt A, Pervez M, Nisar A, Batool U, Shakeel E, Wahab F, Tubassam S, Dawood MH. Effects of Dual-Task Training With and Without Backward Walking on Balance, Functional Mobility, and Participation in Ambulatory Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial. Physiother Res Int. 2027 Jan;32(1):e70371. doi: 10.1002/pri.70371.
PubMed 42967331
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual Task Training With and Without Backward Walking on Balance, Activity and Participation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06407765
- Acronym / sponsor ID
- REC/RCR&AHS/22/0732
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Dual task training, Backward Walking, Activity, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 23 Jul 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 is a non progressive neurodevelopmental disorder that usually effects the muscles of the patients effecting its tone, strength and eventually ability to move. Dual tasking training incorporates more than one task at a time, it can b either physical task with movement or mental tasks. Backward walking is used to challenge the proprioception.
The study is a randomized controlled trial to assess the effects of Dual task training with and without Backward walking on balance, activity and participations on children with cerebral palsy. Study will be conducted in PSRD and Rehab care. Sample will be recruited randomly and then divided into two groups control and experimental group. Control group will receive dual task training and experimental group will receive both dual task training and backward walking. This treatment would continue for 4 weeks. Patient will be assessed both at the start and end of 4 weeks. The outcome tools for assessment of balance, activity and participation will be following: Pediatric Berg Balance Scale, Time up and Go test and Participation of daily life PODCI Questionnaire. Ethical consideration will be followed and informed consent will be taken from legal guardians.
Detailed description
The randomized control trail includes two groups; Control and experimental group. Control group will receive Dual task training. Dual task training incorporates cognitive and motor task. motor task like waking on balance beam is combined with visual memory tasks like pointing towards an object the therapists asks, ask the patient to collect the hanging stars while different shapes are hanging above him, name the object in the picture shown to patient. This treatment will continue for 4 weeks, 4 times a week for 40 minutes.
Experimental group will receive both Dual task training and Backward walking. with the activities mentioned above patient will be asked to walk backward with any obstacle firstly with complete physiotherapist assistance and then gradually with less assistance. Secondly patients will be asked to cover a distance of 15 m through the treatment room's hallway while holding a safety bar with the hand on the unaffected side. Third, without using a safety bar, the participants were urged to walk freely. Lastly, the participants tried to walk backwards at a reasonable pace while progressively increasing their distance travelled and speed. the duration of the treatment will be the same. The patients will be assessed first at the start of treatment and then at the end of 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be a Randomized control trail. Convenient random sampling is used to collect the sample. The population under study is Cerebral palsy children. The study sample group are between the age of 6 to 12. The group is randomly divided into two groups; Control and experimental group. The control group will receive Dual task training. The experimental group will receive both dual task training and backward walking. The patients will be assesed at the start and then after 4 weeks of treatment.
| Arm | Type | Receives |
|---|---|---|
| Dual Task Training | Active comparator | Other: Dual task trainingThis group will receive Dual task training |
| Dual task training with Backward walking | Experimental | Other: Dual task training with backward walkingThis group will receive both Dual task training with Backward walking |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with cerebral palsy who have already received a diagnosis
- Children with GMFCS Level I-II
- Children between the ages of 6 and 12
Key exclusion criteria (5 listed)
- Being unable to complete the cognitive task, which involves counting back one after each number between 0 and 100
- Posing a behavioral issue that makes it challenging to engage in the study
- Being unable to walk independently
- Children with concomitant cardiac conditions
- Any musculoskeletal surgery performed during the previous six months
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 |
|---|---|---|
| Dual task trainingDual task training incorporates both cognitive and motor tasks. Tasks like walking and asking the patient to point towards objects, collect start from the objects hanging above the patient and asking the patient to name the objects shown to him/her. This treatment will be given for 4 weeks, 4 times a week for 40 minutes. Each task is done for 7 minutes with a 3 minutes break in between. | Other | Dual Task Training |
| Dual task training with backward walkingThis group will get both dual task training and backward walking. For dual task training same protocol as active comparator is followed. For backward walking; the patient is firstly asked to walk backward with complete physiotherapist assistance. Secondly, the patient is asked to walk for 15 m through the treatment room's hallway while holding a safety bar with the hand on the unaffected side. Third, without using a safety bar, the participants were urged to walk freely. Lastly, the participants tried to walk backwards at a reasonable pace while progressively increasing their distance travelled and speed. This treatment will be given for 4 weeks, 4 times a week for 40 minutes. Each task is done for 7 minutes with a 3 minutes break in between. | Other | Dual task training with Backward walking |
Primary outcome
Pediatric Berg Balance Scale
Time frame: 4 weeks
A version of Berg's Balance Scale, the Pediatrics Balance Scale (PBS) was created as a balancing assessment for school-age children with mild to moderate motor deficits. There is a 0.998 intra-class correlation value (ICC).
Time up and go test
Time frame: 4 weeks
In clinical practice, the "timed up and go" (TUG) test is a brief assessment tool used to evaluate adults' functional mobility. The TUG test has a high level of dependability in children as well, with an ICC of 0.99 both within a session and between tests.
Participation of Daily Life PODCI Questionnaire
Time frame: 4 weeks
The PODCI is a parent-reported outcome measure that evaluates children's expectations of healthcare interventions as well as their mobility, physical function, comfort, and happiness. When assessing quality of life issues and walking function in children with cerebral palsy, the PODCI shows good validity and reliability.
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 30 Jul 2024.
- Background: PubMed 28509631Fisher-Pipher S Pt Dpt, Kenyon LK Pt Dpt PhD Pcs, Westman M Pt Dpt. Improving balance, mobility, and dual-task performance in an adolescent with cerebral palsy: A case report. Physiother Theory Pract. 2017 Jul;33(7):586-595. doi: 10.1080/09593985.2017.1323359. Epub 2017 May 16.
- Derived from this study: PubMed 42967331Butt A, Pervez M, Nisar A, Batool U, Shakeel E, Wahab F, Tubassam S, Dawood MH. Effects of Dual-Task Training With and Without Backward Walking on Balance, Functional Mobility, and Participation in Ambulatory Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial. Physiother Res Int. 2027 Jan;32(1):e70371. doi: 10.1002/pri.70371.
- 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.
Aqsa Butt, 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 Dual task training and Dual task training with backward walking in people with 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 5 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 30 Jul 2024. 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 Berg Balance Scale (time frame: 4 weeks). The study lists 3 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 NCT06407765, which also lists 2 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 30 Jul 2024.