Spastic Diplegia Cerebral PalsyNCT07870135
Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
A study testing Dual-Task oriented and Traditional Physical Therapy Program in people with Spastic Diplegia Cerebral Palsy, run by Raneem Ahmad Mohammad Ashshi at 1 site in Egypt.
Trial summary
This randomized controlled trial aims to investigate the effect of dual-task oriented training on functional performance in children with spastic diplegic cerebral palsy. Participants will be randomly assigned to two groups. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Spastic Diplegia Cerebral Palsy
- What is being tested?
- Dual-Task oriented and Traditional Physical Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children diagnosed with spastic diplegic cerebral palsy.
- GMFCS levels I-III.
- Aged 4-18 years.
- Able to follow simple commands.
- Modified Ashworth Scale score from 0 to +1.
Who cannot join
- Visual or hearing impairments.
- Cardiovascular disease.
- Fixed musculoskeletal deformities.
- Orthopedic surgery within the previous 6 months.
- Botulinum toxin injections within the previous 6 months.
- History of uncontrolled seizures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
kafrelsheikh University
Cairo
Raneem Ahmad Ashshi, +96659418081, raneem3shi@gmail.com
About this study
Official title: Impact of Dual-Task Oriented Training on Functional Performance in Children With Spastic Diplegic Cerebral Palsy.
This randomized controlled trial aims to investigate the effect of dual-task oriented training on functional performance in children with spastic diplegic cerebral palsy. Participants will be randomly assigned to two groups. The experimental group will receive a designed physical therapy program combined with dual-task oriented training, while the control group will receive the designed physical therapy program only. The study will evaluate changes in gait and balance before and after the intervention. Gait performance will be assessed using spatiotemporal gait parameters, and functional balance will be assessed using the Pediatric Balance Scale.
- Conditions
- Spastic Diplegia Cerebral Palsy
- Being tested
- Dual-Task oriented, Traditional Physical Therapy Program
- Keywords
- Dual-Task Training, Gait, Balance, Functional Performance, Pediatric Physical Therapy
- Medical subject headings
- Cerebral palsy, spastic, diplegic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task orientedBehavioural
Participants will perform dual-task oriented training consisting of motor and cognitive dual-task activities during gait and balance exercises. The training includes walking while performing concurrent motor tasks, such as holding or bouncing a ball, and cognitive tasks while walking. Task difficulty will be progressively increased according to the participant's ability.
Traditional Physical Therapy ProgramBehavioural
Participants will receive a traditional physical therapy program including stretching exercises, standing and balance training, and walking exercises
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will receive the designed physical therapy program combined with dual-task oriented training. Receives: Behavioral: Dual-Task oriented |
| Traditional Physical Therapy Group | Active comparator | Participants in this group will receive the traditional physical therapy exercise program only Receives: Behavioral: Traditional Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Velocity
Gait velocity will be assessed using Kinovea video analysis software and reported in meters per second (m/s).
Measured: Baseline and immediately after completion of the intervention
Secondary outcomes (1)
Change in Functional Balance
Functional balance will be assessed using the Pediatric Balance Scale (PBS). The scale consists of 14 items, with each item scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating better functional balance.
Measured: Baseline and immediately after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegia 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
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raneem Ahmad Mohammad Ashshi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raneem Ahmad Mohammad Ashshi, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870135
- Sponsor's protocol ID
- raneem3shi
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of the participating children.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dual-Task Oriented Training on Functional Performance in Children With Spastic Diplegic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT07870135
- Acronym / sponsor ID
- raneem3shi
- Conditions
- Spastic Diplegia Cerebral Palsy
- Keywords
- Dual-Task Training, Gait, Balance, Functional Performance, Pediatric Physical Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Raneem Ahmad Mohammad AshshiUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 13 Oct 2026 (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.
This randomized controlled trial aims to investigate the effect of dual-task oriented training on functional performance in children with spastic diplegic cerebral palsy. Participants will be randomly assigned to two groups. The experimental group will receive a designed physical therapy program combined with dual-task oriented training, while the control group will receive the designed physical therapy program only. The study will evaluate changes in gait and balance before and after the intervention. Gait performance will be assessed using spatiotemporal gait parameters, and functional balance will be assessed using the Pediatric Balance Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Dual-Task orientedParticipants will receive the designed physical therapy program combined with dual-task oriented training. |
| Traditional Physical Therapy Group | Active comparator | Behavioral: Traditional Physical Therapy ProgramParticipants in this group will receive the traditional physical therapy exercise program only |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children diagnosed with spastic diplegic cerebral palsy.
- GMFCS levels I-III.
- Aged 4-18 years.
- Able to follow simple commands.
- Modified Ashworth Scale score from 0 to +1.
Key exclusion criteria (6 listed)
- Visual or hearing impairments.
- Cardiovascular disease.
- Fixed musculoskeletal deformities.
- Orthopedic surgery within the previous 6 months.
- Botulinum toxin injections within the previous 6 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 orientedParticipants will perform dual-task oriented training consisting of motor and cognitive dual-task activities during gait and balance exercises. The training includes walking while performing concurrent motor tasks, such as holding or bouncing a ball, and cognitive tasks while walking. Task difficulty will be progressively increased according to the participant's ability. | Behavioural | Experimental Group |
| Traditional Physical Therapy ProgramParticipants will receive a traditional physical therapy program including stretching exercises, standing and balance training, and walking exercises | Behavioural | Traditional Physical Therapy Group |
Primary outcome
Change in Gait Velocity
Time frame: Baseline and immediately after completion of the intervention
Gait velocity will be assessed using Kinovea video analysis software and reported in meters per second (m/s).
1 secondary outcome
Change in Functional Balance
Time frame: Baseline and immediately after completion of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of the participating children.
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Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
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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.
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 oriented and Traditional Physical Therapy Program in people with Spastic Diplegia Cerebral Palsy, run by Raneem Ahmad Mohammad Ashshi at 1 site in Egypt.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raneem Ahmad Ashshi, BSc (+966594180851, raneem3shi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Velocity (time frame: Baseline and immediately after completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.