NCT05242796

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

January 8, 2022

Last Update Submit

February 7, 2022

Conditions

Spastic Cerebral Palsy

Outcome Measures

Primary Outcomes (22)

  • 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

    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.

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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.

    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

    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.

    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

    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.

    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

    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.

    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

    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.

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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.

    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

    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.

    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

    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.

    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

    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.

    baseline, 4th week, 8th week and 12th week

Study Arms (3)

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

Interventions

Low frequency magnetic therapyDEVICE
12 sessions of magnet24 sessions of magnetPlacebo magnet intervention

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind randomized clinical trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sr. Physical Therapy Specialist

Study Record Dates

First Submitted

January 8, 2022

First Posted

February 16, 2022

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

March 1, 2016

Last Updated

February 16, 2022

Record last verified: 2022-02