Cerebral Palsy, Spastic, DiplegicHEP&CPNCT05111236
Potential Benefits of Home Based Exercise Programs in the Management of Spastic Cerebral Palsy
A study testing Routine physical therapy and Traditional massage in people with Cerebral Palsy, Spastic, Diplegic, run by National Institute of Rehabilitation Medicine, Islamabad, Pakistan at 1 site in Pakistan.
Trial summary
The study will be conducted to see the potential benefits of home based exercise program comprising routine physical therapy and traditional massage in the management of spastic cerebral palsy (CP). It will be a randomized controlled trial having two groups, RPT group and Massage group. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Diplegic
- What is being tested?
- Routine physical therapy and Traditional massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2021to Jun 2022
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child should have established diagnosis of spastic cerebral palsy (diplegic types only).
Who cannot join
- Children having moderate to severe contractures.
- Children having moderate to severe mental retardation and with multiple disabilities.
- Children with Attention Deficit Hyperactive Disorder (ADHD), uncontrolled seizures and behavioral disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
National Institute of Rehabilitation Medicine (NIRM)
Islamabad, Federal Capital, 44000
Qamar Mahmood, PhD, +923335151063, qamarpt@gmail.com
About this study
Official title: Potential Benefits of Home Based Exercise Programs With and Without Traditional Massage in the Management of Spastic Cerebral Palsy: A Randomized Controlled Trial.
The study will be conducted to see the potential benefits of home based exercise program comprising routine physical therapy and traditional massage in the management of spastic cerebral palsy (CP). It will be a randomized controlled trial having two groups, RPT group and Massage group. Both groups will be provided with routine physical therapy treatment comprising stretching of spastic muscles, strengthening of weak muscles, positioning and posturing strategies. Massage group will also receive traditional massage in addition to routine physical therapy. Parents/Caregivers will be trained to perform routine physical therapy and traditional massage at home. Data will collected using a structured questionnaire, Modified Ashworth Scale (MAS), Gross Motor Function Measure (GMFM),Gross Motor Function Classification System (GMFCS) and CP Child's Caregiver Priorities \& Child Health Index of Life with Disabilities at baseline, after 6th and 12th weeks of intervention.
Read the detailed description
CP is among the most common type of physical disabilities presenting itself in children across the globe. Although its incidence range has been reported from 2 to 2.5 cases per 1000 live births globally, however it may be many folds in poor counties due to lack of reporting and absence of CP registries at national level . Many interventions are in use to manage the disabling and lifelong consequences of this condition. However majority of these interventions remain beyond the reach of poor population especially in under developed countries with poor socio-economic status like Pakistan. This creates a need for search to such interventions which should be locally available, accessible, low cost, affordable, and doable by the poor population so that disabling consequences of this condition may be minimized. RPT and traditional massage performed by parents at home after proper training fall in the category of such low cost interventions. Hence there is dire need to investigate the potential benefits of such interventions. That is why this RCT has been planned.
- Conditions
- Cerebral Palsy, Spastic, Diplegic
- Being tested
- Routine physical therapy, Traditional massage
- Keywords
- cerebral palsy, massage, spasticity, motor function
- Medical subject headings
- Cerebral palsy, spastic, diplegic, Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine physical therapyOther
Rehabilitation strategies in management of children with spastic CP
Traditional massageOther
Rehabilitation strategies in management of children with spastic CP
| Study group | Role | What they receive |
|---|---|---|
| RPT Group | Active comparator | Routine physical therapy comprising stretching of spastic muscles, Strengthening of weak muscles, positioning ( how to make sitting and standing postures at home) and posturing strategies. This whole regimen will be practiced fives times a week for a period of twelve weeks.
Other Names:
• Routine Physical Therapy Receives: Other: Routine physical therapy |
| Massage Group | Experimental | Traditional massage of thirty minutes duration ( five minutes of massage will be provided to all four limbs, front and back of trunk area) prior to routine physical therapy. Routine physical therapy comprising stretching of spastic muscles, Strengthening of weak muscles, positioning ( how to make sitting and standing postures at home) and posturing strategies.
Other Names:
• Routine physical therapy and Traditional massage Receives: Other: Routine physical therapy; Other: Traditional massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth scale (MAS)
0 = No increase in muscle tone
- 1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
- 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range Of Motion (ROM)
- 2 = More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- 3 = Considerable increase in muscle tone, passive movement difficult.
- 4 = Affected part(s) rigid in flexion or extension
Measured: Twelve weeks
Secondary outcomes (3)
Gross motor Function Measure (GMFM-88)
It is used to check the gross motor ability having total of 88 items to be checked in 05 different domain Lying and Rolling (total score 51), Sitting (Total score 60), Crawling and Kneeling( total 42), standing (total 39), walking running jumping (total 72)
Measured: Twelve weeks
Gross Motor Function Classification System (GMFCS)
It has five levels I to V showing the mobility level. Level I to III represent ambulatory status while IV and V represent Non- ambulatory status
Measured: Twelve weeks
CPCHILD ( Caregiver Priorities & child health index of life with Disabilities
It is used to check the quality of life of children with cerebral palsy. It has 09 sections to be completed representing different states related to quality of life.
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Nov 2021
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, Spastic, DiplegicStudies 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
- It is a RCT with two groups, RPT and Massage. Both groups will receive routine physical therapy (with addition of traditional massage in Massage group only) five days a week for a period of 12 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Rehabilitation Medicine, Islamabad, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qamar Mahmood, Principal investigator, HOD, Physiotherapy Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111236
- Sponsor's protocol ID
- NIRM-Physio/01
- Acronym
- HEP&CP
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirby RS, Wingate MS, Van Naarden Braun K, Doernberg NS, Arneson CL, Benedict RE, Mulvihill B, Durkin MS, Fitzgerald RT, Maenner MJ, Patz JA, Yeargin-Allsopp M. Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: a report from the Autism and Developmental Disabilities Monitoring Network. Res Dev Disabil. 2011 Mar-Apr;32(2):462-9. doi: 10.1016/j.ridd.2010.12.042. Epub 2011 Jan 26.
PubMed 21273041Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. doi: 10.1016/s0004-9514(14)60183-5.
PubMed 12600249Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9.
PubMed 16437058Reddihough DS, Jiang B, Lanigan A, Reid SM, Walstab JE, Davis E. Social outcomes of young adults with cerebral palsy. J Intellect Dev Disabil. 2013 Sep;38(3):215-22. doi: 10.3109/13668250.2013.788690. Epub 2013 May 14.
PubMed 23672634Hurvitz EA, Leonard C, Ayyangar R, Nelson VS. Complementary and alternative medicine use in families of children with cerebral palsy. Dev Med Child Neurol. 2003 Jun;45(6):364-70. doi: 10.1017/s0012162203000707.
PubMed 12785436Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
PubMed 23962350Mahmood Q, Habibullah S, Babur MN. Potential effects of traditional massage on spasticity and gross motor function in children with spastic cerebral palsy: A randomized controlled trial. Pak J Med Sci. 2019 Sep-Oct;35(5):1210-1215. doi: 10.12669/pjms.35.5.478.
PubMed 31488980Novak I, Berry J. Home program intervention effectiveness evidence. Phys Occup Ther Pediatr. 2014 Nov;34(4):384-9. doi: 10.3109/01942638.2014.964020. Epub 2014 Oct 15. No abstract available.
PubMed 25317927Mahmood Q, Habibullah S, Aurakzai HU. Effectiveness of simple and basic home-based exercise programs including pediatric massage executed by caregivers at their homes in the management of children with spastic cerebral palsy: A randomized controlled trial. J Pediatr Rehabil Med. 2024;17(1):97-106. doi: 10.3233/PRM-220135.
PubMed 38427509
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Benefits of Home Based Exercise Programs With and Without Traditional Massage in the Management of Spastic Cerebral Palsy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05111236
- Acronym / sponsor ID
- HEP&CP / NIRM-Physio/01
- Conditions
- Cerebral Palsy, Spastic, Diplegic
- Keywords
- cerebral palsy, massage, spasticity, motor function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- National Institute of Rehabilitation Medicine, Islamabad, PakistanUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 Nov 2021 (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 study will be conducted to see the potential benefits of home based exercise program comprising routine physical therapy and traditional massage in the management of spastic cerebral palsy (CP). It will be a randomized controlled trial having two groups, RPT group and Massage group. Both groups will be provided with routine physical therapy treatment comprising stretching of spastic muscles, strengthening of weak muscles, positioning and posturing strategies. Massage group will also receive traditional massage in addition to routine physical therapy. Parents/Caregivers will be trained to perform routine physical therapy and traditional massage at home. Data will collected using a structured questionnaire, Modified Ashworth Scale (MAS), Gross Motor Function Measure (GMFM),Gross Motor Function Classification System (GMFCS) and CP Child's Caregiver Priorities \& Child Health Index of Life with Disabilities at baseline, after 6th and 12th weeks of intervention.
Detailed description
CP is among the most common type of physical disabilities presenting itself in children across the globe. Although its incidence range has been reported from 2 to 2.5 cases per 1000 live births globally, however it may be many folds in poor counties due to lack of reporting and absence of CP registries at national level . Many interventions are in use to manage the disabling and lifelong consequences of this condition. However majority of these interventions remain beyond the reach of poor population especially in under developed countries with poor socio-economic status like Pakistan. This creates a need for search to such interventions which should be locally available, accessible, low cost, affordable, and doable by the poor population so that disabling consequences of this condition may be minimized. RPT and traditional massage performed by parents at home after proper training fall in the category of such low cost interventions. Hence there is dire need to investigate the potential benefits of such interventions. That is why this RCT has been planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It is a RCT with two groups, RPT and Massage. Both groups will receive routine physical therapy (with addition of traditional massage in Massage group only) five days a week for a period of 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| RPT Group | Active comparator | Other: Routine physical therapyRoutine physical therapy comprising stretching of spastic muscles, Strengthening of weak muscles, positioning ( how to make sitting and standing postures at home) and posturing strategies. This whole regimen will be practiced fives times a week for a period of twelve weeks. Other Names: • Routine Physical Therapy |
| Massage Group | Experimental | Other: Routine physical therapy, Other: Traditional massageTraditional massage of thirty minutes duration ( five minutes of massage will be provided to all four limbs, front and back of trunk area) prior to routine physical therapy. Routine physical therapy comprising stretching of spastic muscles, Strengthening of weak muscles, positioning ( how to make sitting and standing postures at home) and posturing strategies. Other Names: • Routine physical therapy and Traditional massage |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child should have established diagnosis of spastic cerebral palsy (diplegic types only).
Key exclusion criteria (3 listed)
- Children having moderate to severe contractures.
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 therapyRehabilitation strategies in management of children with spastic CP | Other | Massage Group, RPT Group |
| Traditional massageRehabilitation strategies in management of children with spastic CP | Other | Massage Group |
Primary outcome
Modified Ashworth scale (MAS)
Time frame: Twelve weeks
0 = No increase in muscle tone * 1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range Of Motion (ROM) * 2 = More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3 = Considerable increase in muscle tone, passive movement difficult. * 4 = Affected part(s) rigid in flexion or extension
3 secondary outcomes
Gross motor Function Measure (GMFM-88)
Time frame: Twelve weeks
Gross Motor Function Classification System (GMFCS)
Time frame: Twelve weeks
CPCHILD ( Caregiver Priorities & child health index of life with Disabilities
Time frame: Twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Background: PubMed 21273041Kirby RS, Wingate MS, Van Naarden Braun K, Doernberg NS, Arneson CL, Benedict RE, Mulvihill B, Durkin MS, Fitzgerald RT, Maenner MJ, Patz JA, Yeargin-Allsopp M. Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: a report from the Autism and Developmental Disabilities Monitoring Network. Res Dev Disabil. 2011 Mar-Apr;32(2):462-9. doi: 10.1016/j.ridd.2010.12.042. Epub 2011 Jan 26.
- Background: PubMed 12600249Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. doi: 10.1016/s0004-9514(14)60183-5.
- Background: PubMed 16437058Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9.
- Background: PubMed 23672634Reddihough DS, Jiang B, Lanigan A, Reid SM, Walstab JE, Davis E. Social outcomes of young adults with cerebral palsy. J Intellect Dev Disabil. 2013 Sep;38(3):215-22. doi: 10.3109/13668250.2013.788690. Epub 2013 May 14.
- Background: PubMed 12785436Hurvitz EA, Leonard C, Ayyangar R, Nelson VS. Complementary and alternative medicine use in families of children with cerebral palsy. Dev Med Child Neurol. 2003 Jun;45(6):364-70. doi: 10.1017/s0012162203000707.
- Background: PubMed 23962350Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
- Background: PubMed 31488980Mahmood Q, Habibullah S, Babur MN. Potential effects of traditional massage on spasticity and gross motor function in children with spastic cerebral palsy: A randomized controlled trial. Pak J Med Sci. 2019 Sep-Oct;35(5):1210-1215. doi: 10.12669/pjms.35.5.478.
- Background: PubMed 25317927Novak I, Berry J. Home program intervention effectiveness evidence. Phys Occup Ther Pediatr. 2014 Nov;34(4):384-9. doi: 10.3109/01942638.2014.964020. Epub 2014 Oct 15. No abstract available.
- Derived from this study: PubMed 38427509Mahmood Q, Habibullah S, Aurakzai HU. Effectiveness of simple and basic home-based exercise programs including pediatric massage executed by caregivers at their homes in the management of children with spastic cerebral palsy: A randomized controlled trial. J Pediatr Rehabil Med. 2024;17(1):97-106. doi: 10.3233/PRM-220135.
- 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.
Qamar Mahmood principal investigator
HOD, Physiotherapy Department
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 and Traditional massage in people with Cerebral Palsy, Spastic, Diplegic, run by National Institute of Rehabilitation Medicine, Islamabad, Pakistan 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 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: status not confirmed, as of the sponsor's last update on 5 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qamar Mahmood (Mahmood, qamarpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth scale (MAS) (time frame: Twelve 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 NCT05111236, which also lists 9 linked publications.
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 5 Jan 2022.