Cerebral PalsyNCT05315102
Effects of Intensive Chiropractic Care to Usual Care for Children With Cerebral Palsy.
A study testing Chiropractic Care and Physical therapy intervention in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in spastic cerebral Palsy children. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Chiropractic Care and Physical therapy intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Apr 2022to 1 Oct 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants will be recruited into the study according to the following criteria.
- Both gender (Male and Female).
- Age between 2 to 15 years.
- Spastic Cerebral Palsy children.
Who cannot join
- Participants will be excluded from the study according to the following criteria.
- Cerebral Palsy children due to Traumatic Brain Injury.
- Patients having cognitive impairments.
- Patients having associated Neurological Pathologies.
- Patients who are unable to follow treatment plan.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Institute of rehabilitation medicine.
Islamabad, Federal, 44000
About this study
Official title: To Investigate the Effects of Three Weeks of Intensive Chiropractic Care When Added to Usual Care for Children With Cerebral Palsy.
To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in spastic cerebral Palsy children.
- Conditions
- Cerebral Palsy
- Being tested
- Sham intervention, Chiropractic Care, Physical therapy intervention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham interventionOther
The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust
Chiropractic CareOther
A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.
Physical therapy interventionOther
The standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Cerebral Palsy children, where Conventional Therapy will be provided according to the respective needs of the individual patient.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. Receives: Other: Chiropractic Care; Other: Physical therapy intervention |
| Control group | Sham comparator | The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor.No spinal adjustment will be performed during any control intervention. Receives: Other: Sham intervention; Other: Physical therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure
The gross motor function measure is a standard instrument that measures the change in motor function with time in Cerebral palsy subjects. It assesses the number of motor tasks a child can perform.
A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. the higher score, the greater is Gross motor function.
Measured: 3 weeks
Trunk Control Measurement Scale (TCMS)
TCMS is an extended version of the trunk impairment scale with a total score of 58, which assesses the quality of static and dynamic trunk control.
The maximum value for the total TCMS is 58 points (20 for the category 'static sitting balance', 28 for 'selective movement control', and 10 for 'dynamic reaching'). A higher TCMS score indicates better performance in trunk control.
Measured: 3 weeks
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered as one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function.
Scoring is completed across the 30 score items using a three, four or five-point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale.
Measured: 3 weeks
Canadian Occupation Performance Measure (COPM)
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention.
Total scores are calculated by adding together the performance or satisfaction scores for all problems and dividing them by the number of problems. At reassessment, the client scores each problem again for performance and satisfaction.
Measured: 3 weeks
Cerebral Palsy Quality Of Life scale (CP-QOL)
The CP-QOL-child is a condition-specific QOL questionnaire designed for children with CP. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators.
The greater the score, the better is the quality of life.
Measured: 3 weeks
Smartphone app for gait and Balance Assessment
This embedded inertial sensor-based smartphone application can provide a valid and reliable estimation of several gaits and balance parameters. The smartphone app for gait and balance assessment will be used on the subject who can walk independently.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start7 Apr 2022
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Research
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IMRAN AMJAD, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315102
- Sponsor's protocol ID
- REC/01285 Imran Amjad
- Status last verified
- Sep 2024
- First submitted
- 30 Mar 2022
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effects of Three Weeks of Intensive Chiropractic Care When Added to Usual Care for Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT05315102
- Acronym / sponsor ID
- REC/01285 Imran Amjad
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 7 Apr 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.
To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in spastic cerebral Palsy children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Research
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Chiropractic Care, Other: Physical therapy interventionA registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. |
| Control group | Sham comparator | Other: Sham intervention, Other: Physical therapy interventionThe participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor.No spinal adjustment will be performed during any control intervention. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants will be recruited into the study according to the following criteria.
- Both gender (Male and Female).
- Age between 2 to 15 years.
- Spastic Cerebral Palsy children.
Key exclusion criteria (5 listed)
- Participants will be excluded from the study according to the following criteria.
- Cerebral Palsy children due to Traumatic Brain Injury.
- Patients having cognitive impairments.
- Patients having associated Neurological Pathologies.
- Patients who are unable to follow treatment plan.
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 |
|---|---|---|
| Sham interventionThe participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust | Other | Control group |
| Chiropractic CareA registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. | Other | Experimental group |
| Physical therapy interventionThe standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Cerebral Palsy children, where Conventional Therapy will be provided according to the respective needs of the individual patient. | Other | Control group, Experimental group |
Primary outcome
Gross Motor Function Measure
Time frame: 3 weeks
The gross motor function measure is a standard instrument that measures the change in motor function with time in Cerebral palsy subjects. It assesses the number of motor tasks a child can perform. A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. the higher score, the greater is Gross motor function.
Trunk Control Measurement Scale (TCMS)
Time frame: 3 weeks
TCMS is an extended version of the trunk impairment scale with a total score of 58, which assesses the quality of static and dynamic trunk control. The maximum value for the total TCMS is 58 points (20 for the category 'static sitting balance', 28 for 'selective movement control', and 10 for 'dynamic reaching'). A higher TCMS score indicates better performance in trunk control.
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Time frame: 3 weeks
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered as one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Scoring is completed across the 30 score items using a three, four or five-point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale.
Canadian Occupation Performance Measure (COPM)
Time frame: 3 weeks
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. Total scores are calculated by adding together the performance or satisfaction scores for all problems and dividing them by the number of problems. At reassessment, the client scores each problem again for performance and satisfaction.
Cerebral Palsy Quality Of Life scale (CP-QOL)
Time frame: 3 weeks
The CP-QOL-child is a condition-specific QOL questionnaire designed for children with CP. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The greater the score, the better is the quality of life.
Smartphone app for gait and Balance Assessment
Time frame: 3 weeks
This embedded inertial sensor-based smartphone application can provide a valid and reliable estimation of several gaits and balance parameters. The smartphone app for gait and balance assessment will be used on the subject who can walk independently.
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 Sep 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.
IMRAN AMJAD, PhD 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 Chiropractic Care and Physical therapy intervention in people with Cerebral Palsy, 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 4 inclusion and 5 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 Sep 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. 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?
Gross Motor Function Measure (time frame: 3 weeks). The study lists 6 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 Sep 2024.