Cerebral PalsyNCT06444230
Effects of Routine Physical Therapy With and Without Neurodevelopmental Technique on GMF, Spasticity and HRQOL in Diplegic CP
A study testing Routine Physical therapy with Neurodevelopmental technique and Routine Physical therapy in people with Cerebral Palsy, run by University of Lahore at 1 site in Pakistan.
Trial summary
The aim of this study is to investigate the effects of routine physical therapy with and without neurodevelopmental technique on gross motor function, spasticity and health related quality of life in diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Routine Physical therapy with Neurodevelopmental technique and Routine Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Jul 2023to 1 Apr 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with an age of 8 to 18 years of both genderswith confirm diagnosis of diplegic cerebral palsy
- Patients could ambulate functionally
- Patients having limited or no prior exposure to NDT
- Individuals with mild to moderate diplegic cerebral palsy, based on established classification scales (GMFM grade I-III)
Who cannot join
- Patients with other motor or sensory dysfunctions and unable to understand and obey commands
- Patient undergone any orthopedic surgery that was ought to treatspasticity
- Patients with spasticity level 4-5 according to Modified Ashworth Scale
- Patients with Botulinum toxins type A injection within last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Routine Physical Therapy With And Without Neuro-Developmental Technique On Gross Motor Function, Spasticity And Health Related Quality Of Life In Diplegic Cerebral Palsy- A Randomized Controlled Trail
The aim of this study is to investigate the effects of routine physical therapy with and without neurodevelopmental technique on gross motor function, spasticity and health related quality of life in diplegic cerebral palsy.
Read the detailed description
The neurological illness known as cerebral palsy is caused by damage to the growing brain and therefore is indicated by anomalies of muscle strength, mobility, and motor functions. Cerebral palsy affects posture, muscle tone, and movement development. Neurodevelopmental technique and routine physical therapy are considered to be effective in treatment of cerebral palsy. This study will investigate the combined effects of neurodevelopmental technique and routine physical therapy versus routine physical therapy on gross motor function, spasticity, and health related quality of life in diplegic cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Routine Physical therapy with Neurodevelopmental technique, Routine Physical therapy
- Keywords
- cerebral palsy, gross motor function, neurodevelopmental technique, health realted quality of life, routine physical therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physical therapy with Neurodevelopmental techniqueOther
participants will recieve a session of 40 minutes including routine physical therapy along with the neurodevelopmental technique for 3 times a week for 12 weeks
Routine Physical therapyOther
participants will recieve a session of 40 minutes including, stretching, neck and trunk stabilization and strengthening exercise followed by a warm up and cool down for 3 times a week for 12 weeks follo
| Study group | Role | What they receive |
|---|---|---|
| Neuro-developmental Physical Therapy+ Routine Physical Therapy | Experimental | * Protocol of 40 minutes focusing on gross motor functional movements including upright sitting at the table, walking, kneeling, running and stair climbing.
* Used a Neuro-developmental method to inhibit undesirable movement patterns and facilitate favorable movement patterns.
* Weight-bearing exercises that involved proprioceptive training while in various positions (such as quadruped, kneeling, half kneeling, and standing).
* Facilitating weight transfer forward, backward, and sideways during balancing reactions from various balance board postures Receives: Other: Routine Physical therapy with Neurodevelopmental technique; Other: Routine Physical therapy |
| Routine Physical therapy: | Experimental | All children in this group received physical therapy of 40 minutes, 3 times per week for 12weeks, which included passive stretching with focus on diplegic limb 8 minutes, neck and trunk postural control for 8 minutes, strength training 8 minutes, ambulation and gait training for 8 minutes with 2 minutes rest interval between each set of exercise. Receives: Other: Routine Physical therapy with Neurodevelopmental technique; Other: Routine Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
UMN syndrome's component of spasticity is an increase in muscular stretch out reflexes that is velocity-dependent and accompanied by an increase in muscle tone. Bryan Ashworth developed the Ashworth Scale in 1964 while treating patients with MS as a way to grade spasticity. The original Ashworth scale, which rated spasticity on a scale of 0 to 4, classified it as either having no resistance or having limbs that were stiff in flexion or extension. They added 1+ to the scale to boost sensitivity(Bohannon \& Smith, 1987). Muscle spasticity is rated using the modified Ashworth scale score ranging from 0 to 4, having total 6 grades
Measured: 9 months
Gross Motor Function Measure
Each item is rated on a four-point ordinal system of assessment. A score of 0 means the task cannot be performed, a score of 1 means the task is able to be started (10% completion), a score of 2 means the task may be completed partially (10% to 100% completion), and a score of 3 means the task is capable of being finished.Every unobserved item on the GMFM-88 receives a score of 0. On the contrast, GMFM-66, however, items that were not seen received a "not tested" or "missing" score.Both versions of GMFM has an excellent reliability
Measured: 9 months
Cerebral Palsy Quality of Life Questionnaire for Children and Adolescent
The Cerebral Palsy Quality of Life for Children (CP QOL-Child) is the very first quality of life survey founded on the International Classification of Function (ICF) created particularly for kids with CP.The CP QOL-Child is available in two versions: the main caregiver-proxy report version (proxy version) for kids ages 4 to 12 and a self-report version for kids ages 9 to 12. The CP QOL-Child's internal consistency, test-retest reliability, and construct validity have all been proven to be reliable and valid.
Measured: 9 months
Secondary outcomes (1)
Manual Muscle Testing
The most popular technique for identifying muscle strength deficits is MMT. According to the dimensions of the muscle and the power of the examiner, scores range from zero contractions to a contraction which can be done against gravity and can withstand the examiner's "maximal" resistance. The examiner rates the muscular groups under study as either "weak" or "strong" on a scale of zero to five while applying force against the participant's resistance
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start27 Jul 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
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.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehzeena Ashraf, University of Lahore
- Investigators
- Shehzeena Ashraf, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444230
- Sponsor's protocol ID
- REC-UOL-536-09-2023
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Routine Physical Therapy With And Without Neuro-Developmental Technique On Gross Motor Function, Spasticity And Health Related Quality Of Life In Diplegic Cerebral Palsy- A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06444230
- Acronym / sponsor ID
- REC-UOL-536-09-2023
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, gross motor function, neurodevelopmental technique, health realted quality of life, routine physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 5 Jun 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.
The aim of this study is to investigate the effects of routine physical therapy with and without neurodevelopmental technique on gross motor function, spasticity and health related quality of life in diplegic cerebral palsy.
Detailed description
The neurological illness known as cerebral palsy is caused by damage to the growing brain and therefore is indicated by anomalies of muscle strength, mobility, and motor functions. Cerebral palsy affects posture, muscle tone, and movement development. Neurodevelopmental technique and routine physical therapy are considered to be effective in treatment of cerebral palsy. This study will investigate the combined effects of neurodevelopmental technique and routine physical therapy versus routine physical therapy on gross motor function, spasticity, and health related quality of life in diplegic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuro-developmental Physical Therapy+ Routine Physical Therapy | Experimental | Other: Routine Physical therapy with Neurodevelopmental technique, Other: Routine Physical therapy* Protocol of 40 minutes focusing on gross motor functional movements including upright sitting at the table, walking, kneeling, running and stair climbing. * Used a Neuro-developmental method to inhibit undesirable movement patterns and facilitate favorable movement patterns. * Weight-bearing exercises that involved proprioceptive training while in various positions (such as quadruped, kneeling, half kneeling, and standing). * Facilitating weight transfer forward, backward, and sideways during balancing reactions from various balance board postures |
| Routine Physical therapy: | Experimental | Other: Routine Physical therapy with Neurodevelopmental technique, Other: Routine Physical therapyAll children in this group received physical therapy of 40 minutes, 3 times per week for 12weeks, which included passive stretching with focus on diplegic limb 8 minutes, neck and trunk postural control for 8 minutes, strength training 8 minutes, ambulation and gait training for 8 minutes with 2 minutes rest interval between each set of exercise. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with an age of 8 to 18 years of both genderswith confirm diagnosis of diplegic cerebral palsy
- Patients could ambulate functionally
- Patients having limited or no prior exposure to NDT
- Individuals with mild to moderate diplegic cerebral palsy, based on established classification scales (GMFM grade I-III)
Key exclusion criteria (4 listed)
- Patients with other motor or sensory dysfunctions and unable to understand and obey commands
- Patient undergone any orthopedic surgery that was ought to treatspasticity
- Patients with spasticity level 4-5 according to Modified Ashworth Scale
- Patients with Botulinum toxins type A injection within last 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 |
|---|---|---|
| Routine Physical therapy with Neurodevelopmental techniqueparticipants will recieve a session of 40 minutes including routine physical therapy along with the neurodevelopmental technique for 3 times a week for 12 weeks | Other | Neuro-developmental Physical Therapy+ Routine Physical Therapy, Routine Physical therapy: |
| Routine Physical therapyparticipants will recieve a session of 40 minutes including, stretching, neck and trunk stabilization and strengthening exercise followed by a warm up and cool down for 3 times a week for 12 weeks follo | Other | Neuro-developmental Physical Therapy+ Routine Physical Therapy, Routine Physical therapy: |
Primary outcome
Modified Ashworth Scale
Time frame: 9 months
UMN syndrome's component of spasticity is an increase in muscular stretch out reflexes that is velocity-dependent and accompanied by an increase in muscle tone. Bryan Ashworth developed the Ashworth Scale in 1964 while treating patients with MS as a way to grade spasticity. The original Ashworth scale, which rated spasticity on a scale of 0 to 4, classified it as either having no resistance or having limbs that were stiff in flexion or extension. They added 1+ to the scale to boost sensitivity(Bohannon \& Smith, 1987). Muscle spasticity is rated using the modified Ashworth scale score ranging from 0 to 4, having total 6 grades
Gross Motor Function Measure
Time frame: 9 months
Each item is rated on a four-point ordinal system of assessment. A score of 0 means the task cannot be performed, a score of 1 means the task is able to be started (10% completion), a score of 2 means the task may be completed partially (10% to 100% completion), and a score of 3 means the task is capable of being finished.Every unobserved item on the GMFM-88 receives a score of 0. On the contrast, GMFM-66, however, items that were not seen received a "not tested" or "missing" score.Both versions of GMFM has an excellent reliability
Cerebral Palsy Quality of Life Questionnaire for Children and Adolescent
Time frame: 9 months
The Cerebral Palsy Quality of Life for Children (CP QOL-Child) is the very first quality of life survey founded on the International Classification of Function (ICF) created particularly for kids with CP.The CP QOL-Child is available in two versions: the main caregiver-proxy report version (proxy version) for kids ages 4 to 12 and a self-report version for kids ages 9 to 12. The CP QOL-Child's internal consistency, test-retest reliability, and construct validity have all been proven to be reliable and valid.
1 secondary outcome
Manual Muscle Testing
Time frame: 9 months
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 6 Jun 2024.
- 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.
Shehzeena Ashraf 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 Routine Physical therapy with Neurodevelopmental technique and Routine Physical therapy in people with Cerebral Palsy, 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 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: finished, as of the sponsor's last update on 6 Jun 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?
Modified Ashworth Scale (time frame: 9 months). 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?
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 6 Jun 2024.