Cerebral PalsyNDTNCT05231538
Neurodevelopmental Therapy for Spastic Cerebral Palsy
A study testing Neurodevelopmental therapy and Routine physical therapy in people with Cerebral Palsy and Spastic, run by University of Lahore at 1 site in Pakistan.
Trial summary
This study was conducted to find out the Effects of Neurodevelopment therapy (a rehabilitative program designed by Bobath) on Gross Motor Function and Postural Control in Children with Spastic Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Diplegia, Spastic
- What is being tested?
- Neurodevelopmental therapy and Routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Jun 2021to 31 Dec 2021
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • A diagnosed Spastic Cerebral Palsy (patient's diagnosis of CP confirmed by an expert pediatrician neurologist)
- Spastic CP
- No other severe abnormalities such as seizure
- Aged 2-6 years
- Both Genders
Who cannot join
- Medical procedures likely to affect motor function such as botulinum toxin injections
- Orthopedic remedial surgery
- Mental retardation, or a learning disability.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Lahore Teaching Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Neurodevelopment Therapy on Gross Motor Function and Postural Control in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
This study was conducted to find out the Effects of Neurodevelopment therapy (a rehabilitative program designed by Bobath) on Gross Motor Function and Postural Control in Children with Spastic Cerebral Palsy. To investigate either there was a significant difference between the effects of neurodevelopment therapy and routine physical therapy on gross motor function and postural control in children with Spastic Cerebral Palsy.
Read the detailed description
A randomized controlled trial was conducted at Department of pediatric rehabilitation, Sher e Rabbani Hospital, Sheikhupura. Sample size was 66 and purposive sampling technique was adopted to collect data. Sample selection was completely based on inclusion and exclusion criteria. A diagnosed Spastic Cerebral Palsy patient aged 2-6 years with no other severe abnormalities such as seizure were recruited. While patients with mental retardation or undergone medical procedures likely to affect motor function such as botulinum toxin injections, orthopedic remedial surgery were excluded. Data was collected at baseline, 4th, 8th and 12th week of the treatment sessions. Gross motor function measure scale (GMFM-88) and posture and postural ability scale (PPAS) were used as data collection tools.
- Conditions
- Cerebral Palsy, Spastic, Diplegia, Spastic
- Being tested
- Neurodevelopmental therapy, Routine physical therapy
- Keywords
- Neurodevelopmental therapy, NDT, Spastic cerebral palsy, Physical Therapy, Rehabilitation, Neurorehabilitation
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental therapyOther
NDT is a hands-on, 'problem solving approach'. It is used in the management and treatment of children who have disorders of function, movement or postural control because of damage in their central nervous system.
Routine physical therapyOther
stretching, passive range of motion, and active range of motion).
| Study group | Role | What they receive |
|---|---|---|
| Neurodevelopmental Therapy | Experimental | The treatment group received neurodevelopment treatment lasting for 3 months (3sessions per week). Additionally, for this study, the NDT programme included passive stretching of the lower limb muscles (e.g. hamstrings, gastrocsoleus), followed by techniques of reducing spasticity and facilitating more normal patterns of movement while working on motor functions. In each session, exercises included patients sustaining themselves on their forearms and hands, sitting, crawling, semi-kneeling, and in standing positions supported by the Physical therapist until tone reduction achieved. Balance and corrective reactions were developed by using a CP ball and tilt board. Receives: Other: Neurodevelopmental therapy |
| Routine Physical Therapy | Active comparator | The control group underwent the exercises (stretching, passive range of motion, and active range of motion). Receives: Other: Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Scale (GMFS)
The Gross motor function scale (GMFS) is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring system of the GMFM is a four-point scale divided into five categories lying and rolling; sitting; crawling and kneeling; standing; walking, running
Measured: 12 weeks
The Posture and Postural Ability Scale (PPAS)
The Posture and Postural Ability Scale (PPAS) is a 7-point ordinal scale for the assessment of postural ability in standing, sitting, supine and prone. There are six items for assessment of quality of posture in the frontal plane and another six items in the sagittal plane
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start17 Jun 2021
- Primary completion15 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Khalid Khan, University of Lahore
- Investigators
- Abdullah Khalid khan, MSNPT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231538
- Sponsor's protocol ID
- IRB-UOL-FAHS/882/2021
- Acronym
- NDT
- Status last verified
- Jan 2022
- First submitted
- 15 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- 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 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurodevelopment Therapy on Gross Motor Function and Postural Control in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05231538
- Acronym / sponsor ID
- NDT / IRB-UOL-FAHS/882/2021
- Conditions
- Cerebral Palsy, Spastic, Diplegia, Spastic
- Keywords
- Neurodevelopmental therapy, NDT, Spastic cerebral palsy, Physical Therapy, Rehabilitation, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Feb 2022 (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 study was conducted to find out the Effects of Neurodevelopment therapy (a rehabilitative program designed by Bobath) on Gross Motor Function and Postural Control in Children with Spastic Cerebral Palsy. To investigate either there was a significant difference between the effects of neurodevelopment therapy and routine physical therapy on gross motor function and postural control in children with Spastic Cerebral Palsy.
Detailed description
A randomized controlled trial was conducted at Department of pediatric rehabilitation, Sher e Rabbani Hospital, Sheikhupura. Sample size was 66 and purposive sampling technique was adopted to collect data. Sample selection was completely based on inclusion and exclusion criteria. A diagnosed Spastic Cerebral Palsy patient aged 2-6 years with no other severe abnormalities such as seizure were recruited. While patients with mental retardation or undergone medical procedures likely to affect motor function such as botulinum toxin injections, orthopedic remedial surgery were excluded. Data was collected at baseline, 4th, 8th and 12th week of the treatment sessions. Gross motor function measure scale (GMFM-88) and posture and postural ability scale (PPAS) were used as data collection tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental Therapy | Experimental | Other: Neurodevelopmental therapyThe treatment group received neurodevelopment treatment lasting for 3 months (3sessions per week). Additionally, for this study, the NDT programme included passive stretching of the lower limb muscles (e.g. hamstrings, gastrocsoleus), followed by techniques of reducing spasticity and facilitating more normal patterns of movement while working on motor functions. In each session, exercises included patients sustaining themselves on their forearms and hands, sitting, crawling, semi-kneeling, and in standing positions supported by the Physical therapist until tone reduction achieved. Balance and corrective reactions were developed by using a CP ball and tilt board. |
| Routine Physical Therapy | Active comparator | Other: Routine physical therapyThe control group underwent the exercises (stretching, passive range of motion, and active range of motion). |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • A diagnosed Spastic Cerebral Palsy (patient's diagnosis of CP confirmed by an expert pediatrician neurologist)
Key exclusion criteria (3 listed)
- Medical procedures likely to affect motor function such as botulinum toxin injections
- Orthopedic remedial surgery
- Mental retardation, or a learning disability.
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 |
|---|---|---|
| Neurodevelopmental therapyNDT is a hands-on, 'problem solving approach'. It is used in the management and treatment of children who have disorders of function, movement or postural control because of damage in their central nervous system. | Other | Neurodevelopmental Therapy |
| Routine physical therapystretching, passive range of motion, and active range of motion). | Other | Routine Physical Therapy |
Primary outcome
Gross Motor Function Scale (GMFS)
Time frame: 12 weeks
The Gross motor function scale (GMFS) is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring system of the GMFM is a four-point scale divided into five categories lying and rolling; sitting; crawling and kneeling; standing; walking, running
The Posture and Postural Ability Scale (PPAS)
Time frame: 12 weeks
The Posture and Postural Ability Scale (PPAS) is a 7-point ordinal scale for the assessment of postural ability in standing, sitting, supine and prone. There are six items for assessment of quality of posture in the frontal plane and another six items in the sagittal plane
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 9 Feb 2022.
- 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.
Abdullah Khalid khan, MSNPT principal investigator
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 Neurodevelopmental therapy and Routine physical therapy in people with Cerebral Palsy and 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 5 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 9 Feb 2022. 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 Scale (GMFS) (time frame: 12 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?
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 9 Feb 2022.