Spastic Diplegic Cerebral PalsyNCT07121426
Effects of LIFT on Gait and Balance in Spastic Diplegic Cerebral Palsy Children
A study testing Lower limb Intensive Functional Training and Conventional physical therapy in people with Spastic Diplegic Cerebral Palsy and Gait, Spastic, run by University of Lahore at 1 site in Pakistan.
Trial summary
The goal of this Randomized control trial was to evaluate the outcome of limb intensive functional training (LIFT) on gait and balance in spastic diplegic cerebral palsy children with age 3-7 years. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy, Gait, Spastic
- What is being tested?
- Lower limb Intensive Functional Training and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jan 2023to 10 Jul 2023
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with Spastic diplegic CP with aged 3-7 years Children of both gender Children with MAS level-2 Children with GMFCS level-3 The ability of caregivers to provide one-on-one attention to the child during dailyactivities
Who cannot join
- Visual problems preventing performance of interventions and testing tasks59 Any orthopedic or neuro-surgery done in last 1 year60 Children with any other neurological conditions61 Children with uncontrolled seizures62
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lower Limb Intensive Functional Training on Gait and Balance in Spastic Diplegic Cerebral Palsy Children
The goal of this Randomized control trial was to evaluate the outcome of limb intensive functional training (LIFT) on gait and balance in spastic diplegic cerebral palsy children with age 3-7 years.
The main questions this study has answered were:
- To access the improvement in children's gait and balance by providing interventions in clinical setting/ standardized environment and then at home environment. This study will check does the improvement in capacity level also improve their performance level in spastic diplegic CP children after getting targeted, activity focused and therapeutic interventions.
- Researcher will compare the effects of intervention on both groups. Control group will receive Conventional physical therapy and traditional gait training at clinical setting while Experimental group will receive LIFT and conventional physical therapy at home settings provided by their caregivers. Both group will receive intervention 5days/week for 20 consecutive weeks.
Read the detailed description
GMFCS level 3 and MAS level 2 children were eligible to participate in study and Gross Motor Functional Measure (GMFM-88) was used to access Motor Capacity. 10-meter walk test, timed up and go test and 30 sec chair rise tests was used to access Motor Performance.
Method and Procedures of the research were explained to the patients earlier to data collection. Any query was explicated on the spot.
Group A: The Control group received conventional physical therapy (Stretching followed by Strengthening program and traditional gait training) at clinical setting.63 Stretching muscles were hip flexors, hip adductors, hamstrings and calf and stretching applied for 30 sec with 30 sec rest for 3-5 times for each muscle group with in pain limit followed by strengthening exercise for week muscle which includes the strengthening of anti-gravity muscles of lower limb they are: Quadriceps, Gluteus maximus and soleus performed in 3 groups. Each group contain 10 rep for each week muscle group. Conventional Physical therapy applied 5 days/week for consecutive 20 weeks. They were also guided to perform activities at home but they're unbound to do the designed activities freely.
Group B: The experimental group received Lower limb intensive functional training (LIFT) at home environment and conventional physical therapy at clinical setting. LIFT was provided at home environment for 3 hours/day, 5days/week for 5 months.31 A log book was maintained and the goals and strategies were guided to child's parents. 3 hours' treatment was performed in intervals at different time of the day. LIFT helped child in motor learning, skill progression and resistance training to target the strength, proprioception and coordination impairments of the lower extremities.64 Motor learning was based on Strength domain (Cycling) and progression from smooth to rough surface. Balance and Coordination domain involves activities such as (ball kicking with alternate legs and Static standing) and progression was done by increasing accuracy and complexity. Proprioception domain (Vertical jumping, sit to stand and cursing) while knee-immobilizers applied if needed and progression number of repetitions and sets was increased over time. Skill progression was used to challenge the LIFT and make it intensive enough to obtain changes in motor skills and function. AFO's were required during therapy session if needed.
Caregiver were provided proper guidelines before implementing the treatment at home. 3 training sessions was given prior to treatment. A log book was also provided to get the structured record of the treatment. Further videos and mode of tele-rehabilitation was used for supervision and guidance throughout the study. Therapist closely monitored the activities by checking daily logs.
- Conditions
- Spastic Diplegic Cerebral Palsy, Gait, Spastic
- Being tested
- Lower limb Intensive Functional Training, Conventional physical therapy
- Keywords
- Cerebral palsy, Balance, Gait, Spastic Diplegia
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower limb Intensive Functional TrainingOther
LIFT will help the child in motor learning, skill progression and resistance training to target the strength, proprioception and coordination impairments of the lower extremities. Motor learning will be based on Strength domain (Cycling) . Balance and Coordination domain involves activities such as (ball kicking with alternate legs and Static standing) Proprioception domain (Vertical jumping, sit to stand and cursing) while applying knee-immobilizers if needed.
Conventional physical therapyOther
Stretching followed by Strengthening program and traditional gait training at clinical setting. Stretching muscles were hip flexors, hip adductors, hamstrings and calf and stretching applied for 30 sec with 30 sec rest for 3-5 times for each muscle group with in pain limit followed by strengthening exercise for week muscle which includes the strengthening of anti-gravity muscles of lower limb they are: Quadriceps, Gluteus maximus and soleus performed in 3 groups. Each group contain 10 rep for each week muscle group.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Control group will receive Conventional physical therapy and traditional gait training at clinical setting. Receives: Other: Conventional physical therapy |
| Intervention Group | Experimental | Experimental group will receive LIFT and conventional physical therapy at home settings provided by their caregivers. Receives: Other: Lower limb Intensive Functional Training; Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor function measure
GMFM-88 version and clause C, D and E will be used in this study.
Measured: at baseline and after 20 weeks
Secondary outcomes (3)
10 Meter Walk Test (10mwt)
10 MWT accesses performance and used for measurement of walking speed over short duration in meter/sec. It is used to calculate the functional mobility and gait
Measured: at baseline and after 20 weeks
Timed Up and Go Test (Tug)
TUG test evaluates balance, anticipatory postural control, functional mobility and agility in ambulatory children with CP. TUG can be used for differentiation in performance with different types of CP and different levels of GMFCS
Measured: at baseline and after 20 weeks
30-sec chair rise test
The 30-sec chair rise test is used to access leg strength and endurance. 30 sec CRT accessed either by a specific number of sit-ups done in 30 second (e.g.; 10 reps, 5 reps etc.) or total repetitions of sit-ups and down done in 30 sec periods
Measured: at baseline and after 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start22 Jan 2023
- Primary completion25 Jun 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spastic Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Umair Ahmed, PhD, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121426
- Sponsor's protocol ID
- REC-UOL-287-01-2023
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2023
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Khumlee N, Suriyaamarit D, Boonyong S. Effects of sensory cues on dynamic trunk control in children with spastic diplegic cerebral palsy. Physiotherapy Theory and Practice 2021: 1-8. 2. Ma Y, Liang Y, Kang X, Shao M, Siemelink L, Zhang Y. Gait characteristics of children with spastic cerebral palsy during inclined treadmill walking under a virtual reality environment. Applied bionics and biomechanics 2019; 2019. 3. Zarkou A, Lee SC, Prosser LA, Jeka JJ. Foot and ankle somatosensory deficits affect balance and motor function in children with cerebral palsy. Frontiers in Human Neuroscience 2020; 14: 45. 4. Tatemoto T, Tanaka S, Maeda K, Tanabe S, Kondo K, Yamaguchi T. Skillful cycling training induces cortical plasticity in the lower extremity motor cortex area in healthy persons. Frontiers in Neuroscience 2019; 13: 927.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lower Limb Intensive Functional Training on Gait and Balance in Spastic Diplegic Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT07121426
- Acronym / sponsor ID
- REC-UOL-287-01-2023
- Conditions
- Spastic Diplegic Cerebral Palsy, Gait, Spastic
- Keywords
- Cerebral palsy, Balance, Gait, Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 13 Aug 2025 (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.
The goal of this Randomized control trial was to evaluate the outcome of limb intensive functional training (LIFT) on gait and balance in spastic diplegic cerebral palsy children with age 3-7 years.
The main questions this study has answered were:
- To access the improvement in children's gait and balance by providing interventions in clinical setting/ standardized environment and then at home environment. This study will check does the improvement in capacity level also improve their performance level in spastic diplegic CP children after getting targeted, activity focused and therapeutic interventions.
- Researcher will compare the effects of intervention on both groups. Control group will receive Conventional physical therapy and traditional gait training at clinical setting while Experimental group will receive LIFT and conventional physical therapy at home settings provided by their caregivers. Both group will receive intervention 5days/week for 20 consecutive weeks.
Detailed description
GMFCS level 3 and MAS level 2 children were eligible to participate in study and Gross Motor Functional Measure (GMFM-88) was used to access Motor Capacity. 10-meter walk test, timed up and go test and 30 sec chair rise tests was used to access Motor Performance.
Method and Procedures of the research were explained to the patients earlier to data collection. Any query was explicated on the spot.
Group A: The Control group received conventional physical therapy (Stretching followed by Strengthening program and traditional gait training) at clinical setting.63 Stretching muscles were hip flexors, hip adductors, hamstrings and calf and stretching applied for 30 sec with 30 sec rest for 3-5 times for each muscle group with in pain limit followed by strengthening exercise for week muscle which includes the strengthening of anti-gravity muscles of lower limb they are: Quadriceps, Gluteus maximus and soleus performed in 3 groups. Each group contain 10 rep for each week muscle group. Conventional Physical therapy applied 5 days/week for consecutive 20 weeks. They were also guided to perform activities at home but they're unbound to do the designed activities freely.
Group B: The experimental group received Lower limb intensive functional training (LIFT) at home environment and conventional physical therapy at clinical setting. LIFT was provided at home environment for 3 hours/day, 5days/week for 5 months.31 A log book was maintained and the goals and strategies were guided to child's parents. 3 hours' treatment was performed in intervals at different time of the day. LIFT helped child in motor learning, skill progression and resistance training to target the strength, proprioception and coordination impairments of the lower extremities.64 Motor learning was based on Strength domain (Cycling) and progression from smooth to rough surface. Balance and Coordination domain involves activities such as (ball kicking with alternate legs and Static standing) and progression was done by increasing accuracy and complexity. Proprioception domain (Vertical jumping, sit to stand and cursing) while knee-immobilizers applied if needed and progression number of repetitions and sets was increased over time. Skill progression was used to challenge the LIFT and make it intensive enough to obtain changes in motor skills and function. AFO's were required during therapy session if needed.
Caregiver were provided proper guidelines before implementing the treatment at home. 3 training sessions was given prior to treatment. A log book was also provided to get the structured record of the treatment. Further videos and mode of tele-rehabilitation was used for supervision and guidance throughout the study. Therapist closely monitored the activities by checking daily logs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Conventional physical therapyControl group will receive Conventional physical therapy and traditional gait training at clinical setting. |
| Intervention Group | Experimental | Other: Lower limb Intensive Functional Training, Other: Conventional physical therapyExperimental group will receive LIFT and conventional physical therapy at home settings provided by their caregivers. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with Spastic diplegic CP with aged 3-7 years Children of both gender Children with MAS level-2 Children with GMFCS level-3 The ability of caregivers to provide one-on-one attention to the child during dailyactivities
Key exclusion criteria (1 listed)
- Visual problems preventing performance of interventions and testing tasks59 Any orthopedic or neuro-surgery done in last 1 year60 Children with any other neurological conditions61 Children with uncontrolled seizures62
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 |
|---|---|---|
| Lower limb Intensive Functional TrainingLIFT will help the child in motor learning, skill progression and resistance training to target the strength, proprioception and coordination impairments of the lower extremities. Motor learning will be based on Strength domain (Cycling) . Balance and Coordination domain involves activities such as (ball kicking with alternate legs and Static standing) Proprioception domain (Vertical jumping, sit to stand and cursing) while applying knee-immobilizers if needed. | Other | Intervention Group |
| Conventional physical therapyStretching followed by Strengthening program and traditional gait training at clinical setting. Stretching muscles were hip flexors, hip adductors, hamstrings and calf and stretching applied for 30 sec with 30 sec rest for 3-5 times for each muscle group with in pain limit followed by strengthening exercise for week muscle which includes the strengthening of anti-gravity muscles of lower limb they are: Quadriceps, Gluteus maximus and soleus performed in 3 groups. Each group contain 10 rep for each week muscle group. | Other | Control Group, Intervention Group |
Primary outcome
Gross motor function measure
Time frame: at baseline and after 20 weeks
GMFM-88 version and clause C, D and E will be used in this study.
3 secondary outcomes
10 Meter Walk Test (10mwt)
Time frame: at baseline and after 20 weeks
Timed Up and Go Test (Tug)
Time frame: at baseline and after 20 weeks
30-sec chair rise test
Time frame: at baseline and after 20 weeks
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 13 Aug 2025.
- Results publication1. Khumlee N, Suriyaamarit D, Boonyong S. Effects of sensory cues on dynamic trunk control in children with spastic diplegic cerebral palsy. Physiotherapy Theory and Practice 2021: 1-8. 2. Ma Y, Liang Y, Kang X, Shao M, Siemelink L, Zhang Y. Gait characteristics of children with spastic cerebral palsy during inclined treadmill walking under a virtual reality environment. Applied bionics and biomechanics 2019; 2019. 3. Zarkou A, Lee SC, Prosser LA, Jeka JJ. Foot and ankle somatosensory deficits affect balance and motor function in children with cerebral palsy. Frontiers in Human Neuroscience 2020; 14: 45. 4. Tatemoto T, Tanaka S, Maeda K, Tanabe S, Kondo K, Yamaguchi T. Skillful cycling training induces cortical plasticity in the lower extremity motor cortex area in healthy persons. Frontiers in Neuroscience 2019; 13: 927.
- 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.
Umair Ahmed, PhD study chair
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower limb Intensive Functional Training and Conventional physical therapy in people with Spastic Diplegic Cerebral Palsy and Gait, Spastic, run by University of Lahore 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 1 inclusion and 1 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 13 Aug 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?
Gross motor function measure (time frame: at baseline and after 20 weeks). 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 NCT07121426, which also lists 1 linked publication.
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 Aug 2025.