Children With Cerebral PalsyNCT03856905
Extracorporeal Shock Wave Therapy Versus Functional Electrical Stimulation on Spasticity, Function and Gait Parameters in Hemiplegic Cerebral Palsy
A study testing Physical therapy program, Extracorporeal shock wave therapy and Functional electrical stimulation in people with Children With Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Objective: The purpose of this study will compare the effects of extracorporeal shock wave therapy (ESWT) versus functional electrical stimulation (FES) on spasticity, function and gait parameters in hemiplegic cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Children With Cerebral Palsy
- What is being tested?
- Physical therapy program, Extracorporeal shock wave therapy and Functional electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2019to 10 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children who demonstrate unilateral dynamic equinus deformity,
- All children must be ambulant independently and they will classified at Gross Motor Function Classification System (GMFCS) levels I or II,
- They must be free from any skeletal abnormalities other than spasticity and the degree of spasticity according to the Modified Ashworth Scale (MAS) within the range of 1+ and 2 grades,
- Moreover, all children must have a minimum five degrees of passive ankle dorsiflexion with knee joint extended
Who cannot join
- The use of botulinum toxin injection of the planter flexor muscles within the 4 months before the study,
- Orthopedic surgery to the ankle joint in the previous 6 months before or during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: The purpose of this study will compare the effects of extracorporeal shock wave therapy (ESWT) versus functional electrical stimulation (FES) on spasticity, function and gait parameters in hemiplegic cerebral palsy (CP).
Methods: Forty-five children with CP ranging in age from 6 to 9 years will be selected and will participate in this study. They will be assigned randomly using opaque envelopes into three groups (A, B and C). Group A will consist of 15 children and will receive the conventional physical therapy program (CPTP) in addition to ankle foot orthosis (AFO). Group B will consist of 15 children and will receive the CPTP, AFO in addition to ESWT. Group C also will consist of 15 children and will receive the CPTP, AFO in addition to FES. The program of treatment will be 3 days/week for 12 weeks. Assessment of spasticity by using the modified ashworth scale (MAS), function by using the pediatric functional independence scale and gait parameters by using the 3-dimensional gait analysis will be conducted at baseline and after 12 weeks of the treatment program.
Read the detailed description
Forty-five children with cerebral palsy (CP) with ages ranging from 6 to 9 years will participate in this study. They will be selected from the out-patient clinic of Obstetric and Pediatric Hospital, Comprehensive Rehabilitation Center, King Khalid Hospital and Najran Generalized Hospital, Najran, KSA, according to inclusive criteria including, children who demonstrate unilateral dynamic equinus deformity, all children must be ambulant independently and they will classified at Gross Motor Function Classification System (GMFCS) levels I or II. They must be free from any skeletal abnormalities other than spasticity and the degree of spasticity according to the Modified Ashworth Scale (MAS) within the range of 1+ and 2 grades. Moreover, all children must have a minimum five degrees of passive ankle dorsiflexion with knee joint extended. Exclusion criteria including, the use of botulinum toxin injection of the planter flexor muscles within the 4 months before the study and orthopedic surgery to the ankle joint in the previous 6 months before or during the study.
Children will be assigned randomly using opaque envelopes into three intervention groups (A, B and C). Group A will receive the conventional physical therapy program (CPTP) in addition to ankle foot orthosis (AFO). Group B will receive the CPTP, AFO in addition to Extra-corporeal shock wave therapy (ESWT), whereas group C will receive CPTP, AFO in addition to functional electrical stimulation (FES). All groups will receive the treatment program 3 sessions/week for 12 weeks. Evaluation of spasticity by using the MAS, function by using the pediatric functional independence scale and gait parameters by using the 3-dimensional gait analysis will be conducted before and after 12 weeks of the treatment program.
- Conditions
- Children With Cerebral Palsy
- Being tested
- Physical therapy program, Extracorporeal shock wave therapy, Functional electrical stimulation
- Keywords
- Cerebral palsy, Extracorporeal Shock Wave Therapy, Functional Electrical Stimulation, Function, Gait, Spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy programOther
It will consist of gentle stretching exercises for spastic muscles, facilitation of muscle contraction for the anti-spastic muscles, proprioceptive training, balance and postural control exercises, neurodevelopmental techniques, and gait training.
Extracorporeal shock wave therapyDevice
It is an electromagnetic coil lithotripter (Modulith SLK; Storz Medical AG, Tagerwillen, Switzerland) provided with in-line ultrasound, radiographic, and computerized aiming (Lithotrack system; Storz Medical AG). The energy applied will be 0.030 mJ/mm2. The frequency will be 5 Hz, with a pressure of 1.5 bars, burst mode.
Functional electrical stimulationDevice
It is a highly advanced medical device that consists of a battery-operated, single-channel electrical stimulator, two electrodes, and electrode leads with a cuff holds the system in place. The stimulation parameters will include pulse frequency (16-33 pulses per second), pulse width (25-300 µs) to produce a desired movement as close to normal as possible at the ankle during gait.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy group | Active comparator | The children in this group will receive the conventional physical therapy program (CPTP). It will consist of gentle stretching exercises for spastic muscles, facilitation of muscle contraction for the anti-spastic muscles, proprioceptive training, balance and postural control exercises, neuro-developmental techniques, and gait training. The total program will be conducted for 1 h, three sessions/week for 12 weeks. Receives: Other: Physical therapy program |
| Extra-corporeal shock wave therapy group | Experimental | The children in this group only will receive the extra-corporeal shock wave therapy (ESWT). An electromagnetic coil lithotripter (Modulith SLK; Storz Medical AG, Tagerwillen, Switzerland) provided with in-line ultrasound, radiographic, and computerized aiming (Lithotrack system; Storz Medical AG) will be used. The energy applied will be 0.030 mJ/mm2. The frequency will be 5 Hz, with a pressure of 1.5 bars, burst mode, one session/week for 12 weeks. The treatment is painless and does not require any kind of anesthesia or the use of analgesic drugs Receives: Other: Physical therapy program; Device: Extracorporeal shock wave therapy |
| Functional electrical stimulation group | Experimental | The children in this group will receive the functional electrical stimulation (FES). The FES will be applied by using the WalkAide system (Innovative Neurotronics, Austin, TX, USA).
The stimulation parameters will include pulse frequency (16-33 pulses per second), pulse width (25-300 µs) to produce a desired movement as close to normal as possible at the ankle during gait. Receives: Other: Physical therapy program; Device: Functional electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity (assessing change between baseline and after treatment)
Name of the scale: The Modified Ashworth Scale. It will be used to measure spasticity of the ankle plantar flexors. It is a simple measure of spasticity giving grades (0, 1, 1+, 2, 3, 4) 0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension The total score will be obtained by calculating the mean of the obtained data Lower scores indicate better results.
Measured: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program
Function (assessing change between baseline and after treatment)
Name of the scale: Functional Independence Measure for Children It will be used to assess the functions of children between 6 months and 12 years.
The scores of the scale extends from minimum 18 (fully dependent) to maximum 126 (fully independent) The scale measures different functional activities in children and the total score will be obtained for each category by computing the mean of the obtained data.
Higher scores indicate better results.
Measured: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Cadence (assessing change between baseline and after treatment)
Cadence will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).
The unit of measure of cadence: steps/minute
Measured: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Stride length (assessing change between baseline and after treatment)
Stride length will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).
The unit of measure of Stride length: meter
Measured: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Velocity (assessing change between baseline and after treatment)
Velocity will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).
The unit of measure of velocity: meter/sec
Measured: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Ankle dorsiflexion angle (assessing change between baseline and after treatment)
Ankle dorsiflexion angle will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).
The unit of measure of Ankle dorsiflexion angle: degrees
Measured: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start10 Apr 2019
- Primary completion10 Apr 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mahmoud Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856905
- Sponsor's protocol ID
- NU/MID/16/025
- Status last verified
- Jul 2019
- First submitted
- 23 Feb 2019
- Last updated
- 24 Jul 2019
- 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 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Therapy Versus Functional Electrical Stimulation on Spasticity, Function and Gait Parameters in Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03856905
- Acronym / sponsor ID
- NU/MID/16/025
- Conditions
- Children With Cerebral Palsy
- Keywords
- Cerebral palsy, Extracorporeal Shock Wave Therapy, Functional Electrical Stimulation, Function, Gait, Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 27 Feb 2019 (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.
Objective: The purpose of this study will compare the effects of extracorporeal shock wave therapy (ESWT) versus functional electrical stimulation (FES) on spasticity, function and gait parameters in hemiplegic cerebral palsy (CP).
Methods: Forty-five children with CP ranging in age from 6 to 9 years will be selected and will participate in this study. They will be assigned randomly using opaque envelopes into three groups (A, B and C). Group A will consist of 15 children and will receive the conventional physical therapy program (CPTP) in addition to ankle foot orthosis (AFO). Group B will consist of 15 children and will receive the CPTP, AFO in addition to ESWT. Group C also will consist of 15 children and will receive the CPTP, AFO in addition to FES. The program of treatment will be 3 days/week for 12 weeks. Assessment of spasticity by using the modified ashworth scale (MAS), function by using the pediatric functional independence scale and gait parameters by using the 3-dimensional gait analysis will be conducted at baseline and after 12 weeks of the treatment program.
Detailed description
Forty-five children with cerebral palsy (CP) with ages ranging from 6 to 9 years will participate in this study. They will be selected from the out-patient clinic of Obstetric and Pediatric Hospital, Comprehensive Rehabilitation Center, King Khalid Hospital and Najran Generalized Hospital, Najran, KSA, according to inclusive criteria including, children who demonstrate unilateral dynamic equinus deformity, all children must be ambulant independently and they will classified at Gross Motor Function Classification System (GMFCS) levels I or II. They must be free from any skeletal abnormalities other than spasticity and the degree of spasticity according to the Modified Ashworth Scale (MAS) within the range of 1+ and 2 grades. Moreover, all children must have a minimum five degrees of passive ankle dorsiflexion with knee joint extended. Exclusion criteria including, the use of botulinum toxin injection of the planter flexor muscles within the 4 months before the study and orthopedic surgery to the ankle joint in the previous 6 months before or during the study.
Children will be assigned randomly using opaque envelopes into three intervention groups (A, B and C). Group A will receive the conventional physical therapy program (CPTP) in addition to ankle foot orthosis (AFO). Group B will receive the CPTP, AFO in addition to Extra-corporeal shock wave therapy (ESWT), whereas group C will receive CPTP, AFO in addition to functional electrical stimulation (FES). All groups will receive the treatment program 3 sessions/week for 12 weeks. Evaluation of spasticity by using the MAS, function by using the pediatric functional independence scale and gait parameters by using the 3-dimensional gait analysis will be conducted before and after 12 weeks of the treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical therapy group | Active comparator | Other: Physical therapy programThe children in this group will receive the conventional physical therapy program (CPTP). It will consist of gentle stretching exercises for spastic muscles, facilitation of muscle contraction for the anti-spastic muscles, proprioceptive training, balance and postural control exercises, neuro-developmental techniques, and gait training. The total program will be conducted for 1 h, three sessions/week for 12 weeks. |
| Extra-corporeal shock wave therapy group | Experimental | Other: Physical therapy program, Device: Extracorporeal shock wave therapyThe children in this group only will receive the extra-corporeal shock wave therapy (ESWT). An electromagnetic coil lithotripter (Modulith SLK; Storz Medical AG, Tagerwillen, Switzerland) provided with in-line ultrasound, radiographic, and computerized aiming (Lithotrack system; Storz Medical AG) will be used. The energy applied will be 0.030 mJ/mm2. The frequency will be 5 Hz, with a pressure of 1.5 bars, burst mode, one session/week for 12 weeks. The treatment is painless and does not require any kind of anesthesia or the use of analgesic drugs |
| Functional electrical stimulation group | Experimental | Other: Physical therapy program, Device: Functional electrical stimulationThe children in this group will receive the functional electrical stimulation (FES). The FES will be applied by using the WalkAide system (Innovative Neurotronics, Austin, TX, USA). The stimulation parameters will include pulse frequency (16-33 pulses per second), pulse width (25-300 µs) to produce a desired movement as close to normal as possible at the ankle during gait. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children who demonstrate unilateral dynamic equinus deformity,
- All children must be ambulant independently and they will classified at Gross Motor Function Classification System (GMFCS) levels I or II,
- They must be free from any skeletal abnormalities other than spasticity and the degree of spasticity according to the Modified Ashworth Scale (MAS) within the range of 1+ and 2 grades,
- Moreover, all children must have a minimum five degrees of passive ankle dorsiflexion with knee joint extended
Key exclusion criteria (2 listed)
- The use of botulinum toxin injection of the planter flexor muscles within the 4 months before the study,
- Orthopedic surgery to the ankle joint in the previous 6 months before or during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy programIt will consist of gentle stretching exercises for spastic muscles, facilitation of muscle contraction for the anti-spastic muscles, proprioceptive training, balance and postural control exercises, neurodevelopmental techniques, and gait training. | Other | Extra-corporeal shock wave therapy group, Functional electrical stimulation group, Physical therapy group |
| Extracorporeal shock wave therapyIt is an electromagnetic coil lithotripter (Modulith SLK; Storz Medical AG, Tagerwillen, Switzerland) provided with in-line ultrasound, radiographic, and computerized aiming (Lithotrack system; Storz Medical AG). The energy applied will be 0.030 mJ/mm2. The frequency will be 5 Hz, with a pressure of 1.5 bars, burst mode. | Device | Extra-corporeal shock wave therapy group |
| Functional electrical stimulationIt is a highly advanced medical device that consists of a battery-operated, single-channel electrical stimulator, two electrodes, and electrode leads with a cuff holds the system in place. The stimulation parameters will include pulse frequency (16-33 pulses per second), pulse width (25-300 µs) to produce a desired movement as close to normal as possible at the ankle during gait. | Device | Functional electrical stimulation group |
Primary outcome
Spasticity (assessing change between baseline and after treatment)
Time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program
Name of the scale: The Modified Ashworth Scale. It will be used to measure spasticity of the ankle plantar flexors. It is a simple measure of spasticity giving grades (0, 1, 1+, 2, 3, 4) 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension The total score will be obtained by calculating the mean of the obtained data Lower scores indicate better results.
Function (assessing change between baseline and after treatment)
Time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Name of the scale: Functional Independence Measure for Children It will be used to assess the functions of children between 6 months and 12 years. The scores of the scale extends from minimum 18 (fully dependent) to maximum 126 (fully independent) The scale measures different functional activities in children and the total score will be obtained for each category by computing the mean of the obtained data. Higher scores indicate better results.
Cadence (assessing change between baseline and after treatment)
Time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Cadence will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of cadence: steps/minute
Stride length (assessing change between baseline and after treatment)
Time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Stride length will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of Stride length: meter
Velocity (assessing change between baseline and after treatment)
Time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Velocity will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of velocity: meter/sec
Ankle dorsiflexion angle (assessing change between baseline and after treatment)
Time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Ankle dorsiflexion angle will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of Ankle dorsiflexion angle: degrees
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 24 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy program, Extracorporeal shock wave therapy and Functional electrical stimulation in people with Children With Cerebral Palsy, run by Cairo University at 1 site in Egypt.
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 2 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Spasticity (assessing change between baseline and after treatment) (time frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program). 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 24 Jul 2019.