Spastic Diplegia Cerebral PalsyELTTS-GFM-SDCPNCT07474818
Loaded and Task Specific Training in Spastic Diaplegic CP to Improve Gait and Functional Mobility.
A study testing Loaded Treadmill Training and Task specific Training in people with Spastic Diplegia Cerebral Palsy, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial summary
Cerebral Palsy is a non-progressive condition caused by early brain injury that affects movement, posture, and muscle tone. Spastic diplegia mainly involves the lower limbs, leading to stiffness, weakness, and abnormal gait patterns. These impairments reduce functional independence and increase caregiver burden. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Spastic Diplegia Cerebral Palsy
- What is being tested?
- Loaded Treadmill Training and Task specific Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2026to 31 Jul 2026
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of Spastic Diplegic Cerebral Palsy
- 6 to 12 years
- Gross Motor Function Classification System Level I to III
- Stand independently or with support
Who cannot join
- Diagnosed with any type other then Spastic Diplegic
- Presence of Comorbidities
- Severe Cognitive and Communicative impairments
- Classified as Gross Motor Function Classification System Level IV and V
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Lahore University of Biological Applied Health Sciences
Lahore, Punjab Province
About this study
Official title: Effects of Loaded Treadmill and Task Specific Training on Gait and Functional Mobility in Children With Spastic Diplegic Cerebral Palsy
Cerebral Palsy is a non-progressive condition caused by early brain injury that affects movement, posture, and muscle tone. Spastic diplegia mainly involves the lower limbs, leading to stiffness, weakness, and abnormal gait patterns.
These impairments reduce functional independence and increase caregiver burden. Loaded Treadmill Training and Task Specific Training are two rehabilitation approaches used to improve strength and Gait function.
This study compares their effectiveness in improving gait and functional mobility in children with spastic diplegic CP.
Read the detailed description
Cerebral Palsy (CP) is the most common non-progressive neurological disorder of childhood, resulting from injury to the developing brain. It is characterized by impaired posture, abnormal movement patterns, and increased muscle tone. Globally, CP affects 2-3.5 per 1000 live births, with an estimated prevalence of 2.5 per 1000 live births in Pakistan. Major risk factors include prematurity, low birth weight, multiple gestations, neonatal jaundice, fetal trauma, hypoxic brain injury, and exposure to toxic substances. Spastic CP is the most common type, frequently affecting the lower limbs. Spasticity, defined as velocity-dependent increase in muscle tone, interferes with voluntary control and increases energy expenditure, leading to muscle weakness, contractures, and skeletal deformities. It results from impaired regulation of motor pathways, particularly corticospinal, reticulospinal, and vestibulospinal tracts. In children with spastic diplegia, altered neural signaling affects muscle growth and morphology, reducing muscle volume, length, and strength. Studies report a 18-50% reduction in muscle size, contributing significantly to muscle weakness around the knee and ankle joints. Spastic diplegia primarily affects the lower extremities, producing gait abnormalities such as toe walking, crouch gait, scissoring, persistent knee flexion, reduced dorsiflexion, decreased stride length, slower walking velocity, and prolonged double limb support. These impairments limit functional independence, restrict participation in daily activities, and reduce quality of life, while also increasing caregiver burden. Improving gait is therefore a major goal of pediatric rehabilitation. Strengthening of lower limb muscles has shown a positive relationship with ambulatory function. Loaded Treadmill Training (LTT) is a resisted strength training approach in which external loads (e.g., ankle weights) are applied during treadmill walking to enhance muscle effort, motor learning, sensory feedback, and walking performance. Resistance is progressively increased, typically around 60% of lower limb weight, according to tolerance. Task-Specific Training (TST) is based on principles of neuroplasticity and motor learning. It involves repetitive practice of functional tasks such as standing, walking, and balance activities in real-life environments. TST enhances muscle strength, coordination, balance, and participation by progressively increasing task difficulty. Two scales are used, Gross Motor Function Measure -88; The interrater and intra-rater reliability of the GMFM-88 total score, assessed with the intra-class correlation coefficient (ICC), are both 0.99. Validity was confirmed by a correlation of 0.82, Jakes Analysis; Observational gait analysis has high validity of 0.94. Inter observer reliability is moderately high and is 0.76 while the intra observer reliability is also high that is 0.89. Both interventions are commonly combined with routine physiotherapy and neurodevelopmental treatment (NDT) approaches to improve motor control. Although both LTT and TST demonstrate beneficial effects on gait and functional mobility in children with spastic diplegic CP, there is limited evidence directly comparing their effectiveness. Therefore, this study aims to determine and compare the effects of Loaded Treadmill Training and Task-Specific Training on gait parameters and functional mobility in children with spastic diplegic cerebral palsy, with the goal of enhancing independence and reducing caregiver burden.
- Conditions
- Spastic Diplegia Cerebral Palsy
- Being tested
- Loaded Treadmill Training, Task specific Training
- Keywords
- Spastic Cerebral Palsy, Gait Training, Functional Mobility, Loaded Treadmill Training, Task Specific Training, Gross Motor Function
- Medical subject headings
- Cerebral palsy, spastic, diplegic, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded Treadmill TrainingDevice
loaded treadmill training is a gait rehabilitation approach in which children walk on a treadmill while external loads (such as ankle weights) are applied to the lower limbs. The load is gradually increased to enhance muscle strength, motor learning, and walking performance. This intervention helps improve stride length, cadence, gait velocity, and overall functional mobility in children with spastic diplegic cerebral palsy.
Task specific TrainingOther
Task-specific training is a rehabilitation approach based on repetitive practice of functional activities. Children perform tasks such as standing, walking, stepping, and balance activities in a structured therapy program. This approach aims to enhance coordination, strength, motor control, and functional mobility in children with spastic diplegic cerebral palsy.
| Study group | Role | What they receive |
|---|---|---|
| Loaded Treadmil Training + Conventional Therapy | Experimental | Participants in the intervention will receive Loaded Treadmill Training for 40 minutes, 3 times per week, for 6 weeks. The session consists of three bouts of treadmill training with two 5-minute breaks. The treadmill's walking speed will be increased gradually. Additionally, conventional therapy will be given for 40 minutes 3 times per week, for 6 weeks Receives: Device: Loaded Treadmill Training |
| Task-Specific Training + Conventional Therapy | Active comparator | Participants in this arm will receive Task-Specific Training (TST) for 40 minutes per session, 3 times per week, for 6 weeks.
The sessions will include a 5-minute warm-up, 30 minutes of functional activities (progressing in difficulty every two weeks), and a 5-minute cool-down.
Additionally, participants will receive 40 minutes of Conventional Physical Therapy per session, 3 times per week for 6 weeks. Receives: Other: Task specific Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Parameter: Cadence
Cadence, defined as the step rate or rhythm of the walk, will be measured in steps per minute. This data will be collected and analyzed using the Jakcs Observational Gait Analysis, a 66-item clinical evaluation checklist designed to systematically observe, identify, and document abnormalities or deviations in patient walking patterns.
Measured: Baseline and after 6 weeks
Change in Gait Parameter: Velocity
Walking velocity (speed) will be measured in meters per minute. This parameter will be assessed and documented using the abbreviated 66-item Jakcs Observational Gait Analysis checklist.
Measured: Baseline and 6 weeks
Change in Gait Parameter: Stride Length
Stride length, which is the measurement of the forward distance covered during two successive points of contact made by the same foot, will be measured in meters. This will be recorded using the Jakcs Observational Gait Analysis tool.
Measured: Baseline and after 6 weeks
Change in Functional Mobility
Functional mobility will be assessed using Dimension E (Walking, Running \& Jumping) of the Gross Motor Function Measure-88 (GMFM-88). The GMFM-88 is a standardized observational instrument designed to assess functional mobility in children with cerebral palsy. It has five dimensions. The items in Dimension E are scored, and the total is calculated by averaging these percentages, where a higher percentage indicates better functional mobility and independence.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion23 Apr 2026 (estimated)
- Study completion31 Jul 2026 (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
- Model description
- Not Needed
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore University of Biological and Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Misha Zahid, Lahore University of Biological and Applied Sciences
- Investigators
- Najam Zia Zia ul Haq, Doctor of Physical therapy, Principal investigator, Lahore College of physical therapyLaiba Nadeem Nadeem, Doctor of Physical Therapy, Principal investigator, Lahore College of Physical TherapyAyesha Fatima, Doctor of Physical Therapy, Principal investigator, Lahore College of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474818
- Sponsor's protocol ID
- DPT/ERB/34
- Other IDs
- U1111-1335-7052
- Acronym
- ELTTS-GFM-SDCP
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Loaded Treadmill and Task Specific Training on Gait and Functional Mobility in Children With Spastic Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07474818
- Acronym / sponsor ID
- ELTTS-GFM-SDCP / DPT/ERB/34
- Conditions
- Spastic Diplegia Cerebral Palsy
- Keywords
- Spastic Cerebral Palsy, Gait Training, Functional Mobility, Loaded Treadmill Training, Task Specific Training, Gross Motor Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 23 Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 16 Mar 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.
Cerebral Palsy is a non-progressive condition caused by early brain injury that affects movement, posture, and muscle tone. Spastic diplegia mainly involves the lower limbs, leading to stiffness, weakness, and abnormal gait patterns.
These impairments reduce functional independence and increase caregiver burden. Loaded Treadmill Training and Task Specific Training are two rehabilitation approaches used to improve strength and Gait function.
This study compares their effectiveness in improving gait and functional mobility in children with spastic diplegic CP.
Detailed description
Cerebral Palsy (CP) is the most common non-progressive neurological disorder of childhood, resulting from injury to the developing brain. It is characterized by impaired posture, abnormal movement patterns, and increased muscle tone. Globally, CP affects 2-3.5 per 1000 live births, with an estimated prevalence of 2.5 per 1000 live births in Pakistan. Major risk factors include prematurity, low birth weight, multiple gestations, neonatal jaundice, fetal trauma, hypoxic brain injury, and exposure to toxic substances. Spastic CP is the most common type, frequently affecting the lower limbs. Spasticity, defined as velocity-dependent increase in muscle tone, interferes with voluntary control and increases energy expenditure, leading to muscle weakness, contractures, and skeletal deformities. It results from impaired regulation of motor pathways, particularly corticospinal, reticulospinal, and vestibulospinal tracts. In children with spastic diplegia, altered neural signaling affects muscle growth and morphology, reducing muscle volume, length, and strength. Studies report a 18-50% reduction in muscle size, contributing significantly to muscle weakness around the knee and ankle joints. Spastic diplegia primarily affects the lower extremities, producing gait abnormalities such as toe walking, crouch gait, scissoring, persistent knee flexion, reduced dorsiflexion, decreased stride length, slower walking velocity, and prolonged double limb support. These impairments limit functional independence, restrict participation in daily activities, and reduce quality of life, while also increasing caregiver burden. Improving gait is therefore a major goal of pediatric rehabilitation. Strengthening of lower limb muscles has shown a positive relationship with ambulatory function. Loaded Treadmill Training (LTT) is a resisted strength training approach in which external loads (e.g., ankle weights) are applied during treadmill walking to enhance muscle effort, motor learning, sensory feedback, and walking performance. Resistance is progressively increased, typically around 60% of lower limb weight, according to tolerance. Task-Specific Training (TST) is based on principles of neuroplasticity and motor learning. It involves repetitive practice of functional tasks such as standing, walking, and balance activities in real-life environments. TST enhances muscle strength, coordination, balance, and participation by progressively increasing task difficulty. Two scales are used, Gross Motor Function Measure -88; The interrater and intra-rater reliability of the GMFM-88 total score, assessed with the intra-class correlation coefficient (ICC), are both 0.99. Validity was confirmed by a correlation of 0.82, Jakes Analysis; Observational gait analysis has high validity of 0.94. Inter observer reliability is moderately high and is 0.76 while the intra observer reliability is also high that is 0.89. Both interventions are commonly combined with routine physiotherapy and neurodevelopmental treatment (NDT) approaches to improve motor control. Although both LTT and TST demonstrate beneficial effects on gait and functional mobility in children with spastic diplegic CP, there is limited evidence directly comparing their effectiveness. Therefore, this study aims to determine and compare the effects of Loaded Treadmill Training and Task-Specific Training on gait parameters and functional mobility in children with spastic diplegic cerebral palsy, with the goal of enhancing independence and reducing caregiver burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Not Needed
| Arm | Type | Receives |
|---|---|---|
| Loaded Treadmil Training + Conventional Therapy | Experimental | Device: Loaded Treadmill TrainingParticipants in the intervention will receive Loaded Treadmill Training for 40 minutes, 3 times per week, for 6 weeks. The session consists of three bouts of treadmill training with two 5-minute breaks. The treadmill's walking speed will be increased gradually. Additionally, conventional therapy will be given for 40 minutes 3 times per week, for 6 weeks |
| Task-Specific Training + Conventional Therapy | Active comparator | Other: Task specific TrainingParticipants in this arm will receive Task-Specific Training (TST) for 40 minutes per session, 3 times per week, for 6 weeks. The sessions will include a 5-minute warm-up, 30 minutes of functional activities (progressing in difficulty every two weeks), and a 5-minute cool-down. Additionally, participants will receive 40 minutes of Conventional Physical Therapy per session, 3 times per week for 6 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Confirmed diagnosis of Spastic Diplegic Cerebral Palsy
- 6 to 12 years
- Gross Motor Function Classification System Level I to III
- Stand independently or with support
Key exclusion criteria (4 listed)
- Diagnosed with any type other then Spastic Diplegic
- Presence of Comorbidities
- Severe Cognitive and Communicative impairments
- Classified as Gross Motor Function Classification System Level IV and V
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 |
|---|---|---|
| Loaded Treadmill Trainingloaded treadmill training is a gait rehabilitation approach in which children walk on a treadmill while external loads (such as ankle weights) are applied to the lower limbs. The load is gradually increased to enhance muscle strength, motor learning, and walking performance. This intervention helps improve stride length, cadence, gait velocity, and overall functional mobility in children with spastic diplegic cerebral palsy. | Device | Loaded Treadmil Training + Conventional Therapy |
| Task specific TrainingTask-specific training is a rehabilitation approach based on repetitive practice of functional activities. Children perform tasks such as standing, walking, stepping, and balance activities in a structured therapy program. This approach aims to enhance coordination, strength, motor control, and functional mobility in children with spastic diplegic cerebral palsy. | Other | Task-Specific Training + Conventional Therapy |
Primary outcome
Change in Gait Parameter: Cadence
Time frame: Baseline and after 6 weeks
Cadence, defined as the step rate or rhythm of the walk, will be measured in steps per minute. This data will be collected and analyzed using the Jakcs Observational Gait Analysis, a 66-item clinical evaluation checklist designed to systematically observe, identify, and document abnormalities or deviations in patient walking patterns.
Change in Gait Parameter: Velocity
Time frame: Baseline and 6 weeks
Walking velocity (speed) will be measured in meters per minute. This parameter will be assessed and documented using the abbreviated 66-item Jakcs Observational Gait Analysis checklist.
Change in Gait Parameter: Stride Length
Time frame: Baseline and after 6 weeks
Stride length, which is the measurement of the forward distance covered during two successive points of contact made by the same foot, will be measured in meters. This will be recorded using the Jakcs Observational Gait Analysis tool.
Change in Functional Mobility
Time frame: Baseline and after 6 weeks
Functional mobility will be assessed using Dimension E (Walking, Running \& Jumping) of the Gross Motor Function Measure-88 (GMFM-88). The GMFM-88 is a standardized observational instrument designed to assess functional mobility in children with cerebral palsy. It has five dimensions. The items in Dimension E are scored, and the total is calculated by averaging these percentages, where a higher percentage indicates better functional mobility and independence.
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 17 Mar 2026.
- 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.
Najam Zia Zia ul Haq, Doctor of Physical therapy principal investigator
Lahore College of physical therapy
Laiba Nadeem Nadeem, Doctor of Physical Therapy principal investigator
Lahore College of Physical Therapy
Ayesha Fatima, Doctor of Physical Therapy principal investigator
Lahore College of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loaded Treadmill Training and Task specific Training in people with Spastic Diplegia Cerebral Palsy, run by Lahore University of Biological and Applied Sciences 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 4 inclusion and 4 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 17 Mar 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 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?
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 Misha Zahid Zahid, Doctor of Physicall Therapy (03277866777, misha.zahid@ubas.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Parameter: Cadence (time frame: Baseline and after 6 weeks). The study lists 4 primary outcomes in all. 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 17 Mar 2026.