Cerebral Palsy, SpasticNCT03379038
Role Of Physical Therapy In Relieving Constipation In Children With Spastic Cerebral Palsy
A study testing Progressive Physical Therapy and Maintenance Physical Therapy in people with Cerebral Palsy, Spastic, run by Isra University at 1 site in Pakistan.
Trial summary
This study was conducted to determine the effectiveness of Physical Therapy management in relieving constipation among Spastic Cerebral Palsy children. There were two groups, Group A received routine Physical Therapy and Group B received maintenance Physical Therapy (aim to maintain current level of spasticity… Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Progressive Physical Therapy and Maintenance Physical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Dec 2017to 30 Jan 2019
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The inclusion criteria for the recruitment in the study were: spastic CP children on oral feeding with constipation between ages 2-12 years of both genders, spasticity above 1+ grade on modified Ashworth scale, functional activity level between 2-5 grades on gross motor functional classification scale (GMFCS).
Who cannot join
- CP children with other systemic co-morbidities, physical deformity in GIT and intellectual disability were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Isra Institute or Rehabilitation Sciences, Isra University Islamabad
Islamabad
About this study
This study was conducted to determine the effectiveness of Physical Therapy management in relieving constipation among Spastic Cerebral Palsy children. There were two groups, Group A received routine Physical Therapy and Group B received maintenance Physical Therapy (aim to maintain current level of spasticity, functionality to avoid deterioration of conadition as approved by ASRC)
Read the detailed description
Physical therapy makes an integral part of the non-pharmacological, conservative management of cerebral palsy. Routine physical therapy aims to reduce spasticity, improve joint range of motion (ROM), and improve strength and mobility.
Passive ROM and stretching of lower limb and trunk increases parasympathetic activity and thus improves intestinal motility in prolonged bed ridden patients.Abdominal muscle training improves intestinal motility by two ways: mechanically by improving fecal propulsion towards rectum and neurologically by inducing parasympathetic activity to improve intestinal motility.20 Thermotherapy of back and abdomen in chronic constipation patient improves intestinal blood flow and parasympathetic activity.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Progressive Physical Therapy, Maintenance Physical Therapy
- Keywords
- Cerebral Palsy, Spasticity, Constipation, Gross Motor Functional Classification Scale, Defecation Frequency, Constipation Severity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Physical TherapyOther
Stretching of the tight muscle, positioning, abdominal co activation; rolling etc to decrease muscle tone and functional independence.
Maintenance Physical TherapyOther
Same Physical therapy protocol but aim was to maintain current level of spasticity and functioning
| Study group | Role | What they receive |
|---|---|---|
| Progressive Physical Therapy (PPT) | Experimental | Duration: Each child was given 40-minute session. Frequency: Two sets were performed, 5-10 active assisted sit-ups in each set at least once a day. Furthermore, the subjects were advised to use CP chair and standing frame/wall corner for sitting/standing position respectively for at least 15-30 minutes once a day. These exercises were followed by reflex inhibiting postures in sitting and lying positions.
Total 42 sessions were performed in 6 weeks (7 days/week). Intensity: The aim of the PPT was to improve the patient's level of spasticity, strength and activity level. Receives: Other: Progressive Physical Therapy |
| Maintenance Physical Therapy (MPT) | Placebo comparator | Duration: Each child was given 40-minute session. Frequency: Two sets were performed, 5-10 active assisted sit-ups in each set at least once a day. Furthermore, the subjects were advised to use CP chair and standing frame/wall corner for sitting/standing position respectively for at least 15-30 minutes once a day. These exercises were followed by reflex inhibiting postures in sitting and lying positions. Total 42 sessions were performed in 6 weeks (7 days/week).
Intensity:The aim of the MPT was to maintain the patient's current level of spasticity, strength and activity level. Receives: Other: Maintenance Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spastcity Spasticity
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 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: 6 Weeks
Defecation Frequency (DF)
Defecation frequency less than three times a week was considered constipation and measured by nominal scale 1= twice a month, 2= once a week, 3= twice a week and 4= daily
Measured: 6 weeks
Constipation assessment scale (CAS)
used to determine the severity of constipation. The CAS consists of eight characteristics. Each of these characteristics is given a three point rating scale (0= no problem, 1= some problem, 2= severe problem). These scores are summed up to make a range from 0 for no constipation to 16 for the most severe constipation
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start27 Dec 2017
- Primary completion20 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The two groups were progressive physical therapy group and maintenance physical therapy group. For any given subject, spasticity, defecation frequency and constipation severity evaluations were completed on the same day. Each subject in PPT group completed 6 weeks of physical therapy sessions which were aimed to decrease spasticity, increase ROM, and improve strength and functional activity level. Each subject was evaluated for changes in symptoms on, 2nd week, 4th week and 6th week. In MPT group same protocol was used but the aim was to maintain current status of level of spasticity, ROM, strength and functional activity. After 6 weeks of physical therapy sessions were completed both groups underwent a 2-week washout period to eliminate the effects of 6-week physical therapy. After the washout period subjects were crossed over from PPT group to MPT group and vice versa.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waqar Ahmed Awan, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379038
- Sponsor's protocol ID
- IIRS-IUISB/PHD/007
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Physical Therapy In Relieving Constipation In Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03379038
- Acronym / sponsor ID
- IIRS-IUISB/PHD/007
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral Palsy, Spasticity, Constipation, Gross Motor Functional Classification Scale, Defecation Frequency, Constipation Severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 20 Dec 2017 (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 determine the effectiveness of Physical Therapy management in relieving constipation among Spastic Cerebral Palsy children. There were two groups, Group A received routine Physical Therapy and Group B received maintenance Physical Therapy (aim to maintain current level of spasticity, functionality to avoid deterioration of conadition as approved by ASRC)
Detailed description
Physical therapy makes an integral part of the non-pharmacological, conservative management of cerebral palsy. Routine physical therapy aims to reduce spasticity, improve joint range of motion (ROM), and improve strength and mobility.
Passive ROM and stretching of lower limb and trunk increases parasympathetic activity and thus improves intestinal motility in prolonged bed ridden patients.Abdominal muscle training improves intestinal motility by two ways: mechanically by improving fecal propulsion towards rectum and neurologically by inducing parasympathetic activity to improve intestinal motility.20 Thermotherapy of back and abdomen in chronic constipation patient improves intestinal blood flow and parasympathetic activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The two groups were progressive physical therapy group and maintenance physical therapy group. For any given subject, spasticity, defecation frequency and constipation severity evaluations were completed on the same day. Each subject in PPT group completed 6 weeks of physical therapy sessions which were aimed to decrease spasticity, increase ROM, and improve strength and functional activity level. Each subject was evaluated for changes in symptoms on, 2nd week, 4th week and 6th week. In MPT group same protocol was used but the aim was to maintain current status of level of spasticity, ROM, strength and functional activity. After 6 weeks of physical therapy sessions were completed both groups underwent a 2-week washout period to eliminate the effects of 6-week physical therapy. After the washout period subjects were crossed over from PPT group to MPT group and vice versa.
| Arm | Type | Receives |
|---|---|---|
| Progressive Physical Therapy (PPT) | Experimental | Other: Progressive Physical TherapyDuration: Each child was given 40-minute session. Frequency: Two sets were performed, 5-10 active assisted sit-ups in each set at least once a day. Furthermore, the subjects were advised to use CP chair and standing frame/wall corner for sitting/standing position respectively for at least 15-30 minutes once a day. These exercises were followed by reflex inhibiting postures in sitting and lying positions. Total 42 sessions were performed in 6 weeks (7 days/week). Intensity: The aim of the PPT was to improve the patient's level of spasticity, strength and activity level. |
| Maintenance Physical Therapy (MPT) | Placebo comparator | Other: Maintenance Physical TherapyDuration: Each child was given 40-minute session. Frequency: Two sets were performed, 5-10 active assisted sit-ups in each set at least once a day. Furthermore, the subjects were advised to use CP chair and standing frame/wall corner for sitting/standing position respectively for at least 15-30 minutes once a day. These exercises were followed by reflex inhibiting postures in sitting and lying positions. Total 42 sessions were performed in 6 weeks (7 days/week). Intensity:The aim of the MPT was to maintain the patient's current level of spasticity, strength and activity level. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria for the recruitment in the study were: spastic CP children on oral feeding with constipation between ages 2-12 years of both genders, spasticity above 1+ grade on modified Ashworth scale, functional activity level between 2-5 grades on gross motor functional classification scale (GMFCS).
Key exclusion criteria (1 listed)
- CP children with other systemic co-morbidities, physical deformity in GIT and intellectual disability were excluded from the study.
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 |
|---|---|---|
| Progressive Physical TherapyStretching of the tight muscle, positioning, abdominal co activation; rolling etc to decrease muscle tone and functional independence. | Other | Progressive Physical Therapy (PPT) |
| Maintenance Physical TherapySame Physical therapy protocol but aim was to maintain current level of spasticity and functioning | Other | Maintenance Physical Therapy (MPT) |
Primary outcome
Spastcity Spasticity
Time frame: 6 Weeks
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 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
Defecation Frequency (DF)
Time frame: 6 weeks
Defecation frequency less than three times a week was considered constipation and measured by nominal scale 1= twice a month, 2= once a week, 3= twice a week and 4= daily
Constipation assessment scale (CAS)
Time frame: 6 Weeks
used to determine the severity of constipation. The CAS consists of eight characteristics. Each of these characteristics is given a three point rating scale (0= no problem, 1= some problem, 2= severe problem). These scores are summed up to make a range from 0 for no constipation to 16 for the most severe constipation
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 19 Feb 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Physical Therapy and Maintenance Physical Therapy in people with Cerebral Palsy, Spastic, run by Isra University 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 19 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
Spastcity Spasticity (time frame: 6 Weeks). 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 19 Feb 2019.