Cerebral PalsyNCT06198244
Effect of Transcutaneous Electrical Stimulation on Constipation
A study testing Transcutaneous Electrical Nerve Stimulation(TENS) and Baseline Treatment in people with Cerebral Palsy and Constipation, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy (CP) is a group of non-progressive neurological disorders that affect body movement, muscle coordination, and posture .It is caused by damage in developing brain, usually before or during birth, but can also occur during early childhood. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Cerebral Palsy, Constipation
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation(TENS) and Baseline Treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 1-6years
- Constipation from at least a month
- Labelled constipation according to the Rome IV criteria
- History of severe stool retention
- History of difficult and painful bowel movements
- History of large diameter stool
- Presence large fecal masses in rectum
- In toilet trained children history of obstructing the toilet at least once a week after use of toilet
Who cannot join
- History of indigestion
- History of metabolic disorders
- Hirschsprung's disease
- hypothyroidism
- cystic fibrosis
- previous abdominal or anal sphincter surgery history
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation on Constipation in Children With Cerebral Palsy
Cerebral palsy (CP) is a group of non-progressive neurological disorders that affect body movement, muscle coordination, and posture .It is caused by damage in developing brain, usually before or during birth, but can also occur during early childhood. They may include muscle stiffness or floppiness, abnormal reflexes, impaired coordination, difficulty with fine motor skills, speech and swallowing difficulties, involuntary movements, problems with balance and posture, and intellectual or developmental disabilities. Constipation is a common gastrointestinal issue in children with cerebral palsy (CP) due to reduced muscle tone, impaired coordination, limited mobility, and side effects of certain drugs like antispasmodics or anti-epileptics. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive therapy. Usually, TENS is commonly used as pain management modality, its role in treating constipation in children with cerebral palsy is still being explored. Research on the use of TENS for constipation in children with cerebral palsy is limited, and most studies have focused on constipation in adults or individuals without CP. However, some studies have investigated the effects of TENS on gastrointestinal function in children with CP, including constipation.
This study was Randomized Controlled Trial with random sampling technique. Study was conducted in DHQ Hospital, Hafizabad from July 2023 to December 2023 on 34 children with cerebral palsy with constipation having age from 1 to 6 years according to inclusion and exclusion criteria. After recruitment, it was divided into two Groups. Baseline treatment was provided to control group while TENS will be used in other experimental group. TENS was applied on abdominal area for 20 minutes along with baseline treatment. Record pre and post session history of patient defecation frequency per week, abdominal pain or discomfort, and type of stool via using Rome-IV criteria, Bristol Stool Scale, Constipation Assessment scale and Gross Motor Function Classification System before and after treatment. Data Analyses was based on statistical parameters and comparison performed before and after application of treatment.
Read the detailed description
This was Randomized controlled trial. Study has been conducted in DHQ Hospital, Hafizabad from July 2023 to December 2023 on children with cerebral palsy with constipation. By using convenient sampling technique, participants were recruited according to the inclusion criteria i.e. constipated children with Cerebral Palsy of age from 1-6,having Constipation from at least a month Labelled as constipation according to the Rome IV criteria; having History of severe stool retention, History of difficult and painful bowel movements. History of large diameter stool, Presence large fecal masses in rectum and in toilet trained children history of obstructing the toilet at least once a week after use of toilet. After recruitment, they were divided into two Groups. In interventional group baseline measurements regarding defecation frequency per week, abdominal pain or discomfort, type of stool, quality of life and functional status was recorded before the start of treatment. After taking the readings, apply TENS on abdomen via skin electrodes for a month (20 minutes per session and 3 times a week) along with baseline treatment .In interventional group TENS is applied on the lower gastrointestinal tract, placed these electrodes on the abdomen lateral to the umbilicus and other two skin electrodes applied at back side at T9-L2 level. First place electrodes at front side then at back side. Assess the patient severity of the constipation, frequency and consistency of stool, and abdominal pain before the commencement of treatment by using Bristol Stool Scale (BSS), Romes-IV criteria, Visual Analogue Scale (VAS), and Gross Motor Functional Classification System (GMFS) at baseline and end of last session of the treatment(Pre and post-treatment). In control group, after the recruitment of population according to the inclusion criteria. The baseline measurement were recorded. The baseline treatment was given in which general movements were performed i.e. Double knee-to-chest movement, sitting, standing, rolling included. Each movement is performed by 10 repetition in one set. Again assess the patient severity of constipation, frequency and consistency of stool, abdominal pain and functional status and quality of life at the end of last session of the treatment.
Strict confidentiality of participants' information will be maintained, and data collection will be conducted with the approval of the Institutional Review Board (IRB).
- Conditions
- Cerebral Palsy, Constipation
- Being tested
- Transcutaneous Electrical Nerve Stimulation(TENS), Baseline Treatment
- Keywords
- cerebral palsy, constipation, Pelvic Floor, TENS
- Medical subject headings
- Cerebral Palsy, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation(TENS)Device
Defecation frequency per week, abdominal pain or discomfort, type of stool, severity of the constipation, frequency and consistency of stool, were measured before the commencement of treatment by using Romes-IV criteria, Visual Analogue Scale (VAS),Bristol Stool Scale (BSS),Gross Motor Functional Classification System (GMFCS) and Constipation Assessment Scale(CAS).After taking the measurements apply TENS on abdomen i.e. on the lower gastrointestinal tract, placed two skin electrodes of TENS on the abdomen lateral to the umbilicus and other two electrodes on back side at T9-L2 level for a month (20 minutes per session and 3 times a week) along with baseline treatment in which general movements were performed. After the completion of treatment same tools were used to re-assess the defecation frequency per week, abdominal pain or discomfort, type of stool, and severity of the constipation, frequency and consistency of stool for the measurement of final reading(Pre and post-treatment).
Baseline TreatmentOther
In control group, after the recruitment of participants according to the inclusion criteria. The baseline measurement were recorded by using Romes-IV criteria, Visual Analogue Scale (VAS), Bristol Stool Scale (BSS),Gross Motor Functional Classification System (GMFCS) and Constipation Assessment Scale(CAS). The baseline treatment is given in which general movements were performed i.e. Double knee-to-chest movement, sitting, standing, rolling as well as stretching of calf, hamstrings, adductors of both sides. Again assess the patient severity of constipation, frequency and consistency of stool, abdominal pain and functional status after the end of last session of the treatment(Pre and Post-treatment method).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | TENS was applied on abdomen along with baseline movements and stretches were given to experimental group. Receives: Device: Transcutaneous Electrical Nerve Stimulation(TENS) |
| Control Group | Active comparator | Baseline movements and stretches were given to control group Receives: Other: Baseline Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bristol Stool Scale(BSS)
BSS is a diagnostic tool which is designed to classify the form of human feces into seven categories. Types 1 and 2 indicates constipation, type 3,4 and 5 being the ideal stools, not containing excess liquid, type; 6 and 7 indicates lack of dietary fiber,it indicates diarrhea
Measured: 4 weeks
Romes-IV criteria
Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria Related to defecation Associated with a change in frequency of stool Associated with a change in form (appearance) of stool Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
Measured: 4 weeks
Constipation Assessments Scale (CAS)
Constipation Assessments Scale is a valid and reliable tool consisting of 8 self-reported items investigating the presence and severity of constipation in both children and adults. The scoring is provided by a 3-point rating scale indicating 0= as no constipation,
1 = as some problem, and 2= as severe problem. Total score ranges between 0 (no constipation) and 16 (severe constipation). Although CAS is a self-reported questionnaire, parents or caregivers were asked to answer the questions for those children who were unable to read and/or comprehend the scale because of their age.
Measured: 4 weeks
Visual Analogue Scale(VAS)
VAS is most frequently used to evaluate the degree of pain, it has also been used to assess the burden and the severity of musculoskeletal disorders in various studies. Satisfaction of treatment was measured on a 10-cm scale. Both the children and the caregivers or parents were asked to rate their overall satisfaction between 0(indicating no satisfaction) and 10 (most satisfied).Visual Analogue Scale use is shown to be a valid and reliable assessment method for use in children. The reliability of VAS is .60 to .79 for usual pain and .88 for worst pain.
Gross Motor Functional Classification System(GMFS)(7, 8) The reliability of GMFS is 0.93.It provides an objective classification of the patterns of motor disability in children with CP(20).The GMFCS is a 5 level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ushna Yalnaz, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198244
- Sponsor's protocol ID
- REC/RCR&AHS/23/0761
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soumena RZ, Darma A, Ranuh RG, Gunawan PI, Sumitro KR, Sudarmo SM. Efficacy of transcutaneous electrical nerve stimulation on slow transit constipation in children with cerebral palsy. Bali Medical Journal. 2023;12(1):192-6.
Awan WA, Masood T. Role Of Stretching Exercises In The Management Of Constipation In Spastic Cerebral Palsy. J Ayub Med Coll Abbottabad. 2016 Oct-Dec;28(4):798-801.
PubMed 28586619
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation on Constipation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06198244
- Acronym / sponsor ID
- REC/RCR&AHS/23/0761
- Conditions
- Cerebral Palsy, Constipation
- Keywords
- cerebral palsy, constipation, Pelvic Floor, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 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.
Cerebral palsy (CP) is a group of non-progressive neurological disorders that affect body movement, muscle coordination, and posture .It is caused by damage in developing brain, usually before or during birth, but can also occur during early childhood. They may include muscle stiffness or floppiness, abnormal reflexes, impaired coordination, difficulty with fine motor skills, speech and swallowing difficulties, involuntary movements, problems with balance and posture, and intellectual or developmental disabilities. Constipation is a common gastrointestinal issue in children with cerebral palsy (CP) due to reduced muscle tone, impaired coordination, limited mobility, and side effects of certain drugs like antispasmodics or anti-epileptics. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive therapy. Usually, TENS is commonly used as pain management modality, its role in treating constipation in children with cerebral palsy is still being explored. Research on the use of TENS for constipation in children with cerebral palsy is limited, and most studies have focused on constipation in adults or individuals without CP. However, some studies have investigated the effects of TENS on gastrointestinal function in children with CP, including constipation.
This study was Randomized Controlled Trial with random sampling technique. Study was conducted in DHQ Hospital, Hafizabad from July 2023 to December 2023 on 34 children with cerebral palsy with constipation having age from 1 to 6 years according to inclusion and exclusion criteria. After recruitment, it was divided into two Groups. Baseline treatment was provided to control group while TENS will be used in other experimental group. TENS was applied on abdominal area for 20 minutes along with baseline treatment. Record pre and post session history of patient defecation frequency per week, abdominal pain or discomfort, and type of stool via using Rome-IV criteria, Bristol Stool Scale, Constipation Assessment scale and Gross Motor Function Classification System before and after treatment. Data Analyses was based on statistical parameters and comparison performed before and after application of treatment.
Detailed description
This was Randomized controlled trial. Study has been conducted in DHQ Hospital, Hafizabad from July 2023 to December 2023 on children with cerebral palsy with constipation. By using convenient sampling technique, participants were recruited according to the inclusion criteria i.e. constipated children with Cerebral Palsy of age from 1-6,having Constipation from at least a month Labelled as constipation according to the Rome IV criteria; having History of severe stool retention, History of difficult and painful bowel movements. History of large diameter stool, Presence large fecal masses in rectum and in toilet trained children history of obstructing the toilet at least once a week after use of toilet. After recruitment, they were divided into two Groups. In interventional group baseline measurements regarding defecation frequency per week, abdominal pain or discomfort, type of stool, quality of life and functional status was recorded before the start of treatment. After taking the readings, apply TENS on abdomen via skin electrodes for a month (20 minutes per session and 3 times a week) along with baseline treatment .In interventional group TENS is applied on the lower gastrointestinal tract, placed these electrodes on the abdomen lateral to the umbilicus and other two skin electrodes applied at back side at T9-L2 level. First place electrodes at front side then at back side. Assess the patient severity of the constipation, frequency and consistency of stool, and abdominal pain before the commencement of treatment by using Bristol Stool Scale (BSS), Romes-IV criteria, Visual Analogue Scale (VAS), and Gross Motor Functional Classification System (GMFS) at baseline and end of last session of the treatment(Pre and post-treatment). In control group, after the recruitment of population according to the inclusion criteria. The baseline measurement were recorded. The baseline treatment was given in which general movements were performed i.e. Double knee-to-chest movement, sitting, standing, rolling included. Each movement is performed by 10 repetition in one set. Again assess the patient severity of constipation, frequency and consistency of stool, abdominal pain and functional status and quality of life at the end of last session of the treatment.
Strict confidentiality of participants' information will be maintained, and data collection will be conducted with the approval of the Institutional Review Board (IRB).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation(TENS)TENS was applied on abdomen along with baseline movements and stretches were given to experimental group. |
| Control Group | Active comparator | Other: Baseline TreatmentBaseline movements and stretches were given to control group |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- age 1-6years
- Constipation from at least a month
- Labelled constipation according to the Rome IV criteria
- History of severe stool retention
- History of difficult and painful bowel movements
Key exclusion criteria (6 listed)
- History of indigestion
- History of metabolic disorders
- Hirschsprung's disease
- hypothyroidism
- cystic fibrosis
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation(TENS)Defecation frequency per week, abdominal pain or discomfort, type of stool, severity of the constipation, frequency and consistency of stool, were measured before the commencement of treatment by using Romes-IV criteria, Visual Analogue Scale (VAS),Bristol Stool Scale (BSS),Gross Motor Functional Classification System (GMFCS) and Constipation Assessment Scale(CAS).After taking the measurements apply TENS on abdomen i.e. on the lower gastrointestinal tract, placed two skin electrodes of TENS on the abdomen lateral to the umbilicus and other two electrodes on back side at T9-L2 level for a month (20 minutes per session and 3 times a week) along with baseline treatment in which general movements were performed. After the completion of treatment same tools were used to re-assess the defecation frequency per week, abdominal pain or discomfort, type of stool, and severity of the constipation, frequency and consistency of stool for the measurement of final reading(Pre and post-treatment). | Device | Experimental Group |
| Baseline TreatmentIn control group, after the recruitment of participants according to the inclusion criteria. The baseline measurement were recorded by using Romes-IV criteria, Visual Analogue Scale (VAS), Bristol Stool Scale (BSS),Gross Motor Functional Classification System (GMFCS) and Constipation Assessment Scale(CAS). The baseline treatment is given in which general movements were performed i.e. Double knee-to-chest movement, sitting, standing, rolling as well as stretching of calf, hamstrings, adductors of both sides. Again assess the patient severity of constipation, frequency and consistency of stool, abdominal pain and functional status after the end of last session of the treatment(Pre and Post-treatment method). | Other | Control Group |
Primary outcome
Bristol Stool Scale(BSS)
Time frame: 4 weeks
BSS is a diagnostic tool which is designed to classify the form of human feces into seven categories. Types 1 and 2 indicates constipation, type 3,4 and 5 being the ideal stools, not containing excess liquid, type; 6 and 7 indicates lack of dietary fiber,it indicates diarrhea
Romes-IV criteria
Time frame: 4 weeks
Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria Related to defecation Associated with a change in frequency of stool Associated with a change in form (appearance) of stool Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
Constipation Assessments Scale (CAS)
Time frame: 4 weeks
Constipation Assessments Scale is a valid and reliable tool consisting of 8 self-reported items investigating the presence and severity of constipation in both children and adults. The scoring is provided by a 3-point rating scale indicating 0= as no constipation, 1 = as some problem, and 2= as severe problem. Total score ranges between 0 (no constipation) and 16 (severe constipation). Although CAS is a self-reported questionnaire, parents or caregivers were asked to answer the questions for those children who were unable to read and/or comprehend the scale because of their age.
Visual Analogue Scale(VAS)
Time frame: 4 weeks
VAS is most frequently used to evaluate the degree of pain, it has also been used to assess the burden and the severity of musculoskeletal disorders in various studies. Satisfaction of treatment was measured on a 10-cm scale. Both the children and the caregivers or parents were asked to rate their overall satisfaction between 0(indicating no satisfaction) and 10 (most satisfied).Visual Analogue Scale use is shown to be a valid and reliable assessment method for use in children. The reliability of VAS is .60 to .79 for usual pain and .88 for worst pain. Gross Motor Functional Classification System(GMFS)(7, 8) The reliability of GMFS is 0.93.It provides an objective classification of the patterns of motor disability in children with CP(20).The GMFCS is a 5 level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.
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 Jun 2024.
- BackgroundSoumena RZ, Darma A, Ranuh RG, Gunawan PI, Sumitro KR, Sudarmo SM. Efficacy of transcutaneous electrical nerve stimulation on slow transit constipation in children with cerebral palsy. Bali Medical Journal. 2023;12(1):192-6.
- Background: PubMed 28586619Awan WA, Masood T. Role Of Stretching Exercises In The Management Of Constipation In Spastic Cerebral Palsy. J Ayub Med Coll Abbottabad. 2016 Oct-Dec;28(4):798-801.
- 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.
Ushna Yalnaz, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation(TENS) and Baseline Treatment in people with Cerebral Palsy and Constipation, run by Riphah International 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 8 inclusion and 6 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 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?
Bristol Stool Scale(BSS) (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 NCT06198244, which also lists 2 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 13 Jun 2024.