Spastic Cerebral PalsyNCT05242796
Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy
A study testing Low frequency magnetic therapy in people with Spastic Cerebral Palsy, run by King Fahad Armed Forces Hospital.
Trial summary
Background: Spasticity is a major challenge in patients with cerebral palsy (CP). It may cause unwanted complications and may affect the patient's quality of life. Currently there is no satisfactory long lasting control of spasticity. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Low frequency magnetic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 1 Mar 2016
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A confirmed diagnosis of diplegic or quadriplegic CP of both genders,
- Able to stand without assistance.
- Age from 4-16 years
- Measureable spasticity (1 or more according to the Modified Ashworth Scale).
Who cannot join
- Have recent organ transplants.
- Have heart pace maker.
- Have cardiac arrhythmia, tachy cardiac conditions or large aneurysm.
- Have heavy psychosis.
- Underwent any neuromuscular blockers of Spasticity.
- Underwent any surgery of tendon lengthening before or during the study.
- Have epileptic episodes.
About this study
Official title: Placebo Controlled, Randomized, Double Blind, Clinical Trial of the Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy
Background: Spasticity is a major challenge in patients with cerebral palsy (CP). It may cause unwanted complications and may affect the patient's quality of life. Currently there is no satisfactory long lasting control of spasticity. Many lines of evidence indicate that magnet therapy may be a useful intervention in the management of spasticity. Several studies showed that magnet may inhibit neuronal firing in the human nervous system; however, its effects weren't studied on spasticity. Objectives: The goal of the present study was to determine the short-and long-term effects of pulsed low frequency magnetic field therapy on spasticity in patient with CP. Methods: 48 patients with CP, who have measureable level of spasticity, were selected. The sample was divided randomly into active magnet group (received magnet therapy, 32 subjects) and placebo group (16 subjects). At the end of the 4th week the magnet group was divided into two sub-groups: 1st sub-group received magnet therapy for another 4 weeks while the other received the placebo. Measurements was taken at baseline, 4th, 8th and 12th weeks. Modified Ashworth Scale was used to measure spasticity, foot pressure platform system was used to measure the contact area and the maximum force of the feet, gross motor function measure (GMFM) was used to measure the functional level of the patients. The cerebral palsy quality of life (CP-QoL) questionnaire was used to measure the patients' various dimensions of quality of life.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Low frequency magnetic 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.
Low frequency magnetic therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| 12 sessions of magnet | Experimental | Not described Receives: Device: Low frequency magnetic therapy |
| 24 sessions of magnet | Experimental | Not described Receives: Device: Low frequency magnetic therapy |
| Placebo magnet intervention | Placebo comparator | Not described Receives: Device: Low frequency magnetic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Modified Ashowreth Scale at 4, 8 and 12 weeks
measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Gross Motor Function Scale at 4, 8 and 12 weeks
to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Feet Contact Area at 4, 8 and 12 weeks
The weight distribution between the feet and the ground - Higher grade means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Feet Maximum Force at 4, 8 and 12 weeks
Measuring Feet Maximum Force of the participants - Higher grade means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (1,3,4,5,6,7,10,11,12,13,14,15).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (8,22,23,24,27,29,34,35,37,38,39,40).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (9,16,17,18,19,20,21,25,26,30,37).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (2,28,31,32,33,52).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome.
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (41, 42, 43, 53, 54, 55, 56, 57, 58, 59, 60, 61).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome.
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (44, 45, 46, 47, 48, 49, 50, 51).
- Each item has an answer from one to nine; where (1= not bothered at all) to (9 = very bothered).
- To be calculated by summation of all the dimension's score.
- Higher score means worse outcome.
Measured: baseline, 4th week, 8th week and 12th week
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Family health dimension) at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (62, 63, 64, 65).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome.
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Modified Ashowreth Scale scores between the three groups from baseline at 4, 8 and 12 weeks
measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Gross Motor Function Scale scores between the three groups from baseline at 4, 8 and 12 weeks
to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Feet Contact Area scores between the three groups from baseline at 4, 8 and 12 weeks
The weight distribution between the feet and the ground - Higher grade means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Feet Maximum Force scores between the three groups from baseline at 4, 8 and 12 weeks
Measuring Feet Maximum Force of the participants - Higher grade means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (1,3,4,5,6,7,10,11,12,13,14,15).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (8,22,23,24,27,29,34,35,37,38,39,40).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (9,16,17,18,19,20,21,25,26,30,37).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (2,28,31,32,33,52).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome.
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (41, 42, 43, 53, 54, 55, 56, 57, 58, 59, 60, 61).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome.
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (44, 45, 46, 47, 48, 49, 50, 51).
- Each item has an answer from one to nine; where (1= not bothered at all) to (9 = very bothered).
- To be calculated by summation of all the dimension's score.
- Higher score means worse outcome.
Measured: baseline, 4th week, 8th week and 12th week
Comparison of Cerebral Palsy Quality of Live Questionnaire (Family health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
- Items numbers in the questionnaire: (62, 63, 64, 65).
- Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy.
- To be calculated by summation of all the dimension's score.
- Higher score means better outcome.
Measured: baseline, 4th week, 8th week and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Apr 2014
- Primary completion1 Jun 2015
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies 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
- Double blind randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahad Armed Forces Hospital
- Sponsor type
- Other government
- Collaborators
- Imam Abdulrahman Bin Faisal University
- Responsible party
- Principal investigator, Ali AlGhamdi, King Fahad Armed Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242796
- Sponsor's protocol ID
- KFMMC
- Status last verified
- Feb 2022
- First submitted
- 8 Jan 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled, Randomized, Double Blind, Clinical Trial of the Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05242796
- Acronym / sponsor ID
- KFMMC
- Conditions
- Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- King Fahad Armed Forces HospitalOther government
- Collaborators
- Imam Abdulrahman Bin Faisal University
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 16 Feb 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.
Background: Spasticity is a major challenge in patients with cerebral palsy (CP). It may cause unwanted complications and may affect the patient's quality of life. Currently there is no satisfactory long lasting control of spasticity. Many lines of evidence indicate that magnet therapy may be a useful intervention in the management of spasticity. Several studies showed that magnet may inhibit neuronal firing in the human nervous system; however, its effects weren't studied on spasticity. Objectives: The goal of the present study was to determine the short-and long-term effects of pulsed low frequency magnetic field therapy on spasticity in patient with CP. Methods: 48 patients with CP, who have measureable level of spasticity, were selected. The sample was divided randomly into active magnet group (received magnet therapy, 32 subjects) and placebo group (16 subjects). At the end of the 4th week the magnet group was divided into two sub-groups: 1st sub-group received magnet therapy for another 4 weeks while the other received the placebo. Measurements was taken at baseline, 4th, 8th and 12th weeks. Modified Ashworth Scale was used to measure spasticity, foot pressure platform system was used to measure the contact area and the maximum force of the feet, gross motor function measure (GMFM) was used to measure the functional level of the patients. The cerebral palsy quality of life (CP-QoL) questionnaire was used to measure the patients' various dimensions of quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Double blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| 12 sessions of magnet | Experimental | Device: Low frequency magnetic therapy |
| 24 sessions of magnet | Experimental | Device: Low frequency magnetic therapy |
| Placebo magnet intervention | Placebo comparator | Device: Low frequency magnetic therapy |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A confirmed diagnosis of diplegic or quadriplegic CP of both genders,
- Able to stand without assistance.
- Age from 4-16 years
- Measureable spasticity (1 or more according to the Modified Ashworth Scale).
Key exclusion criteria (7 listed)
- Have recent organ transplants.
- Have heart pace maker.
- Have cardiac arrhythmia, tachy cardiac conditions or large aneurysm.
- Have heavy psychosis.
- Underwent any neuromuscular blockers of Spasticity.
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 |
|---|---|---|
| Low frequency magnetic therapy | Device | 12 sessions of magnet, 24 sessions of magnet, Placebo magnet intervention |
Primary outcome
Change from baseline Modified Ashowreth Scale at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome
Change from baseline Gross Motor Function Scale at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.
Change from baseline Feet Contact Area at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
The weight distribution between the feet and the ground - Higher grade means better outcome
Change from baseline Feet Maximum Force at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
Measuring Feet Maximum Force of the participants - Higher grade means better outcome
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (1,3,4,5,6,7,10,11,12,13,14,15). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (8,22,23,24,27,29,34,35,37,38,39,40). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (9,16,17,18,19,20,21,25,26,30,37). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (2,28,31,32,33,52). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (41, 42, 43, 53, 54, 55, 56, 57, 58, 59, 60, 61). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (44, 45, 46, 47, 48, 49, 50, 51). 2. Each item has an answer from one to nine; where (1= not bothered at all) to (9 = very bothered). 3. To be calculated by summation of all the dimension's score. 4. Higher score means worse outcome.
Change from baseline Cerebral Palsy Quality of Live Questionnaire (Family health dimension) at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (62, 63, 64, 65). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Comparison of Modified Ashowreth Scale scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
measure the muscle resistance following a passive stretch - grades from (0 - 4), lower score means better outcome
Comparison of Gross Motor Function Scale scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
to evaluate the children with CP according to their motor functional ability - Scores (0% - 100%) where higher grade means better outcome.
Comparison of Feet Contact Area scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
The weight distribution between the feet and the ground - Higher grade means better outcome
Comparison of Feet Maximum Force scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
Measuring Feet Maximum Force of the participants - Higher grade means better outcome
Comparison of Cerebral Palsy Quality of Live Questionnaire (Social well-being and acceptance dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (1,3,4,5,6,7,10,11,12,13,14,15). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Comparison of Cerebral Palsy Quality of Live Questionnaire (Functioning dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (8,22,23,24,27,29,34,35,37,38,39,40). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Comparison of Cerebral Palsy Quality of Live Questionnaire (Participation and physical health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (9,16,17,18,19,20,21,25,26,30,37). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome
Comparison of Cerebral Palsy Quality of Live Questionnaire (Emotional well-being dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (2,28,31,32,33,52). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Comparison of Cerebral Palsy Quality of Live Questionnaire (Access to services dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (41, 42, 43, 53, 54, 55, 56, 57, 58, 59, 60, 61). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
Comparison of Cerebral Palsy Quality of Live Questionnaire (Pain and impact of disability dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (44, 45, 46, 47, 48, 49, 50, 51). 2. Each item has an answer from one to nine; where (1= not bothered at all) to (9 = very bothered). 3. To be calculated by summation of all the dimension's score. 4. Higher score means worse outcome.
Comparison of Cerebral Palsy Quality of Live Questionnaire (Family health dimension) scores between the three groups from baseline at 4, 8 and 12 weeks
Time frame: baseline, 4th week, 8th week and 12th week
1. Items numbers in the questionnaire: (62, 63, 64, 65). 2. Each item has an answer from one to nine; where 1= very unhappy, 3 = unhappy, 5 = neither happy nor unhappy, 7 = happy, and 9 = very happy. 3. To be calculated by summation of all the dimension's score. 4. Higher score means better outcome.
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 16 Feb 2022.
Related trials for Spastic Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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.
Questions about this trial
What is this clinical trial studying?
A study testing Low frequency magnetic therapy in people with Spastic Cerebral Palsy, run by King Fahad Armed Forces Hospital.
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 7 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline Modified Ashowreth Scale at 4, 8 and 12 weeks (time frame: baseline, 4th week, 8th week and 12th week). The study lists 22 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 16 Feb 2022.