Cerebral Palsy, SpasticNCT04087330
Whole-body Vibration in Spastic Hemiplegic Cerebral Palsy
A study testing Group 1 Experimental group in people with Cerebral Palsy, Spastic, run by Riphah International University at 1 site in Pakistan.
Trial summary
To target spasticity, balance and mobility whole body vibration exercises along with selected physical therapy is given to experimental group. Control group will receive only selected physical therapy that includes sstretching exercises, gait training, ffacilitation of postural reactions, ffacilitation of standing and… Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Group 1 Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2019to 1 Jan 2020
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ashworth scale score +1-3
- age between 6 and 13 years,
- able to accept and follow verbal instructions,
- Gross Motor Function Classification System [GMFCS] levels I-III),
Who cannot join
- unstable seizures, any treatment for spasticity or surgical procedures from 3 months (for botulinum toxin type A injections)
- Suffering from any other condition that interfered with physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Whole-body Vibration on Spasticity, Balance and Mobility in Spastic Hemiplegic Cerebral Palsy
To target spasticity, balance and mobility whole body vibration exercises along with selected physical therapy is given to experimental group. Control group will receive only selected physical therapy that includes sstretching exercises, gait training, ffacilitation of postural reactions, ffacilitation of standing and weight shift and facilitation of standing balance by using a balance board.
Read the detailed description
Cerebral palsy is the most common childhood disabilities affecting individual's posture and movement. Cerebral palsy is a disorder that causes activity limitations attributed to non-progressive disturbances of the foetal or infant brain that may also affect sensation, perception, cognition, communication, and behavior. Cerebral palsy (CP) results from damage to the developing central nervous system while in utero, during delivery, or during the first two years of life.
The most common movement disorder in Cerebral palsy is a spastic paresis, defined as a posture and movement-dependent tone regulation disorder.The most common signs of the disorder are spasticity, rigidity, muscle weakness, ataxia, balance and movement disorders. Compared to the typically developed children, these children have impaired sensation and increased muscle tone therefore they have trouble voluntarily controlling their muscles. Cerebral Palsy can be grouped based on the motor effects it has on the individual, these can include spastic Cerebral palsy or non-spastic Cerebral palsy. Spastic Cerebral Palsy is the most common type and is associated with tight or contracted muscles.
Cerebral Palsy is more prevalent in more deprived socio-economic populations. Cerebral palsy is a disease that globally has a prevalence of 2 to 3 cases per 1,000 live born neonates. An increase in the prevalence of CP was also seen in low birth weight survivors from the Mersey region of the United Kingdom for the same period. Pilot studies of severe mental retardation conducted in selected populations in Pakistan and India have reported extraordinarily high prevalence estimates in the range of 12-24 /1,000 Spasticity may be defined as a motor disorder characterised by a velocity-dependent exaggeration of stretch reflexes resulting from abnormal intraspinal processing of primary afferent input. The impaired sensation and increase in tone leads to wide range in movement dysfunction. About seventy to eighty percent of children with Cerebral Palsy demonstrate spastic clinical features. Many children with cerebral palsy (CP) have poor walking abilities and manipulation skills. One contributing factor to their problems with gait and reaching movement is poor balance control. Balance control is important as it helps a child to recover from unexpected balance disturbances.Currently, there are many options for the management of spasticity, balance disturbances and risk of fall that includes physical modalities, oral pharmacologic agents, peripheral injectables, intrathecal agents, and surgical interventions, however mostly physical therapy is commonly preferable treatment that includes stretching, NDT, Proprioceptive neuromuscular facilitations,strength training and gait training.
Dynamic mechanical loading of the skeleton is an arduous task and troublesome to induce in children who suffer from severe cerebral palsy. The lack of dynamic weight bearing in this population predisposes them to reduced bone mineral density (BMD) and pre-mature osteoporosis. These children are also more prone to muscle weakness, which contributes to pain, deformity and functional loss. Whole-body vibration training was proposed as a new therapeutic modality for the treatment of the gross motor function, balance and functional performance Whole body vibration (WBV), for which the participant stands on a vibrating platform, delivers low-frequency, low-amplitude mechanical stimuli that enter the human body via the feet. The vibrations stimulate the muscle spindles and alpha motor neuron sending nerve impulses to initiate muscle contractions according to the tonic vibration reflex. Compared to the repetitive passive movement, this WBV protocol adds a muscle strengthening component to the anti-spastic effects. Activity restrictions in spastic cerebral palsy are mainly due to poor postural control. Many interventions like resisting exercises, therapeutic horseback riding, electrical stimulations leads to short term posture and balance improvement. Training using vibration platforms adjunct to exercise has shown to be effective in increasing strength resulting in improved balance and coordination. Whole body vibration has shown to be effective in reducing lower limb spasticity after first application of WBV with a vibration frequency of 12 Hz to 18 Hz ( 2-3 m of amplitude ) for 9 minutes and a significant decrease in tone is observed and even the functional mobility and balance is improved.. During all of the vibration-training sessions, the children will wear the gymnastic shoes to standardize the damping of the vibration due to footwear.
There is paucity in the literature regarding evidence for the safe and effective use of vibration intervention in children with or without pathology and has great effects in spasticity, mobility and improving balance.Chia-Ling Chen concluded that the WBV is an effective intervention for controlling spasticity and improving ambulation. Villarreal et al.showed that 20-week WBV therapy had positive effects on the balance of DS adolescents, although only under specific conditions, with vision and somatosensory input altered.
In previous studies high dosage of whole body vibration has both positive and negative effects. Because this type of treatment seems to improve bone health, The purpose of this intervention is to ensure functional independence in cerebral palsy patients. Whole Body Vibration Therapy has proven to be effective in improving balance by reducing spasticity and improving muscle strength. It is essential to explore new interventions for patients specially for cerebral palsy in whom functional independence is impaired thus their mobility is restricted leading to secondary complications. In my study my goal is to use combination of conventional physical therapy with whole body vibration which can control spasticity and enhance ambulatory performance.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Group 1 Experimental group, Group 2 Control group
- Keywords
- Cerebral Palsy, Spastic, Whole body vibration
- 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.
Group 1 Experimental groupOther
Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles.
Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball.
Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board.
Gait training: by forward, backward, and side-way walking between parallel bars.
Whole body vibration.
Group 2 Control groupOther
Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles.
Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball.
Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board.
Gait training: by forward, backward, and side-way walking between parallel bars.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Experimental group | Experimental | Stretching, facilitation exercises with whole body vibration Receives: Other: Group 1 Experimental group |
| Group 2 Control group | Active comparator | Stretching and facilitation exercises Receives: Other: Group 2 Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth
It is used to check spasticity and consists of 6 grades from 0-4
Measured: Change from Baseline spasticity to 3 months
6-Minute walking test (6MWT)
It is used to test mobility of participant. The 6-minute walk test (6MWT) is a standardized, self-paced walking test commonly used to assess functional ability in different populations.
Measured: Change from Baseline mobility level to 3 months
Paediatric Balance Scale
The Pediatric Balance Scale (PBS), a modification of the BBS, was developed as a balance measure for children with mild to moderate motor impairments and has good test-retest and interrater reliability. The PBS is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks
Measured: Change from Baseline balance to 3 months
Secondary outcomes (2)
Timed Up and Go test (TUG)
TUG is a test used to assess a person's mobility. TUG measured the time required for an individual to stand up from a chair with armrests, walk 3 m, turn, walk back to the chair, and sit down.
Measured: Change from Baseline mobility and balance to 3 months
Sit-To-Stand (STS) test
Sit to stand test is a reliable tool for measuring lower limb functional strength and balance ability.
Measured: Change from Baseline mobility and balance to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start15 Sep 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087330
- Sponsor's protocol ID
- REC/00555 kainat Ameer
- Status last verified
- Nov 2021
- First submitted
- 4 Sep 2019
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng HY, Ju YY, Chen CL, Chuang LL, Cheng CH. Effects of whole body vibration on spasticity and lower extremity function in children with cerebral palsy. Hum Mov Sci. 2015 Feb;39:65-72. doi: 10.1016/j.humov.2014.11.003. Epub 2014 Nov 24.
PubMed 25461434Dickin DC, Faust KA, Wang H, Frame J. The acute effects of whole-body vibration on gait parameters in adults with cerebral palsy. J Musculoskelet Neuronal Interact. 2013 Mar;13(1):19-26.
PubMed 23445911Saquetto M, Carvalho V, Silva C, Conceicao C, Gomes-Neto M. The effects of whole body vibration on mobility and balance in children with cerebral palsy: a systematic review with meta-analysis. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):137-44.
PubMed 26032205Unger M, Jelsma J, Stark C. Effect of a trunk-targeted intervention using vibration on posture and gait in children with spastic type cerebral palsy: a randomized control trial. Dev Neurorehabil. 2013;16(2):79-88. doi: 10.3109/17518423.2012.715313.
PubMed 23477461Matute-Llorente A, Gonzalez-Aguero A, Gomez-Cabello A, Vicente-Rodriguez G, Casajus Mallen JA. Effect of whole-body vibration therapy on health-related physical fitness in children and adolescents with disabilities: a systematic review. J Adolesc Health. 2014 Apr;54(4):385-96. doi: 10.1016/j.jadohealth.2013.11.001. Epub 2014 Jan 1.
PubMed 24388109Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS, Benedict RE, Kirby RS, Durkin MS. Prevalence of cerebral palsy in 8-year-old children in three areas of the United States in 2002: a multisite collaboration. Pediatrics. 2008 Mar;121(3):547-54. doi: 10.1542/peds.2007-1270.
PubMed 18310204
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-body Vibration on Spasticity, Balance and Mobility in Spastic Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04087330
- Acronym / sponsor ID
- REC/00555 kainat Ameer
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral Palsy, Spastic, Whole body vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 12 Sep 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.
To target spasticity, balance and mobility whole body vibration exercises along with selected physical therapy is given to experimental group. Control group will receive only selected physical therapy that includes sstretching exercises, gait training, ffacilitation of postural reactions, ffacilitation of standing and weight shift and facilitation of standing balance by using a balance board.
Detailed description
Cerebral palsy is the most common childhood disabilities affecting individual's posture and movement. Cerebral palsy is a disorder that causes activity limitations attributed to non-progressive disturbances of the foetal or infant brain that may also affect sensation, perception, cognition, communication, and behavior. Cerebral palsy (CP) results from damage to the developing central nervous system while in utero, during delivery, or during the first two years of life.
The most common movement disorder in Cerebral palsy is a spastic paresis, defined as a posture and movement-dependent tone regulation disorder.The most common signs of the disorder are spasticity, rigidity, muscle weakness, ataxia, balance and movement disorders. Compared to the typically developed children, these children have impaired sensation and increased muscle tone therefore they have trouble voluntarily controlling their muscles. Cerebral Palsy can be grouped based on the motor effects it has on the individual, these can include spastic Cerebral palsy or non-spastic Cerebral palsy. Spastic Cerebral Palsy is the most common type and is associated with tight or contracted muscles.
Cerebral Palsy is more prevalent in more deprived socio-economic populations. Cerebral palsy is a disease that globally has a prevalence of 2 to 3 cases per 1,000 live born neonates. An increase in the prevalence of CP was also seen in low birth weight survivors from the Mersey region of the United Kingdom for the same period. Pilot studies of severe mental retardation conducted in selected populations in Pakistan and India have reported extraordinarily high prevalence estimates in the range of 12-24 /1,000 Spasticity may be defined as a motor disorder characterised by a velocity-dependent exaggeration of stretch reflexes resulting from abnormal intraspinal processing of primary afferent input. The impaired sensation and increase in tone leads to wide range in movement dysfunction. About seventy to eighty percent of children with Cerebral Palsy demonstrate spastic clinical features. Many children with cerebral palsy (CP) have poor walking abilities and manipulation skills. One contributing factor to their problems with gait and reaching movement is poor balance control. Balance control is important as it helps a child to recover from unexpected balance disturbances.Currently, there are many options for the management of spasticity, balance disturbances and risk of fall that includes physical modalities, oral pharmacologic agents, peripheral injectables, intrathecal agents, and surgical interventions, however mostly physical therapy is commonly preferable treatment that includes stretching, NDT, Proprioceptive neuromuscular facilitations,strength training and gait training.
Dynamic mechanical loading of the skeleton is an arduous task and troublesome to induce in children who suffer from severe cerebral palsy. The lack of dynamic weight bearing in this population predisposes them to reduced bone mineral density (BMD) and pre-mature osteoporosis. These children are also more prone to muscle weakness, which contributes to pain, deformity and functional loss. Whole-body vibration training was proposed as a new therapeutic modality for the treatment of the gross motor function, balance and functional performance Whole body vibration (WBV), for which the participant stands on a vibrating platform, delivers low-frequency, low-amplitude mechanical stimuli that enter the human body via the feet. The vibrations stimulate the muscle spindles and alpha motor neuron sending nerve impulses to initiate muscle contractions according to the tonic vibration reflex. Compared to the repetitive passive movement, this WBV protocol adds a muscle strengthening component to the anti-spastic effects. Activity restrictions in spastic cerebral palsy are mainly due to poor postural control. Many interventions like resisting exercises, therapeutic horseback riding, electrical stimulations leads to short term posture and balance improvement. Training using vibration platforms adjunct to exercise has shown to be effective in increasing strength resulting in improved balance and coordination. Whole body vibration has shown to be effective in reducing lower limb spasticity after first application of WBV with a vibration frequency of 12 Hz to 18 Hz ( 2-3 m of amplitude ) for 9 minutes and a significant decrease in tone is observed and even the functional mobility and balance is improved.. During all of the vibration-training sessions, the children will wear the gymnastic shoes to standardize the damping of the vibration due to footwear.
There is paucity in the literature regarding evidence for the safe and effective use of vibration intervention in children with or without pathology and has great effects in spasticity, mobility and improving balance.Chia-Ling Chen concluded that the WBV is an effective intervention for controlling spasticity and improving ambulation. Villarreal et al.showed that 20-week WBV therapy had positive effects on the balance of DS adolescents, although only under specific conditions, with vision and somatosensory input altered.
In previous studies high dosage of whole body vibration has both positive and negative effects. Because this type of treatment seems to improve bone health, The purpose of this intervention is to ensure functional independence in cerebral palsy patients. Whole Body Vibration Therapy has proven to be effective in improving balance by reducing spasticity and improving muscle strength. It is essential to explore new interventions for patients specially for cerebral palsy in whom functional independence is impaired thus their mobility is restricted leading to secondary complications. In my study my goal is to use combination of conventional physical therapy with whole body vibration which can control spasticity and enhance ambulatory performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Experimental group | Experimental | Other: Group 1 Experimental groupStretching, facilitation exercises with whole body vibration |
| Group 2 Control group | Active comparator | Other: Group 2 Control groupStretching and facilitation exercises |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ashworth scale score +1-3
- age between 6 and 13 years,
- able to accept and follow verbal instructions,
- Gross Motor Function Classification System [GMFCS] levels I-III),
Key exclusion criteria (2 listed)
- unstable seizures, any treatment for spasticity or surgical procedures from 3 months (for botulinum toxin type A injections)
- Suffering from any other condition that interfered with physical activity.
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 |
|---|---|---|
| Group 1 Experimental groupStretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles. Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball. Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board. Gait training: by forward, backward, and side-way walking between parallel bars. Whole body vibration. | Other | Group 1 Experimental group |
| Group 2 Control groupStretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles. Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball. Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board. Gait training: by forward, backward, and side-way walking between parallel bars. | Other | Group 2 Control group |
Primary outcome
Modified Ashworth
Time frame: Change from Baseline spasticity to 3 months
It is used to check spasticity and consists of 6 grades from 0-4
6-Minute walking test (6MWT)
Time frame: Change from Baseline mobility level to 3 months
It is used to test mobility of participant. The 6-minute walk test (6MWT) is a standardized, self-paced walking test commonly used to assess functional ability in different populations.
Paediatric Balance Scale
Time frame: Change from Baseline balance to 3 months
The Pediatric Balance Scale (PBS), a modification of the BBS, was developed as a balance measure for children with mild to moderate motor impairments and has good test-retest and interrater reliability. The PBS is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks
2 secondary outcomes
Timed Up and Go test (TUG)
Time frame: Change from Baseline mobility and balance to 3 months
Sit-To-Stand (STS) test
Time frame: Change from Baseline mobility and balance to 3 months
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 10 Nov 2021.
- Background: PubMed 25461434Cheng HY, Ju YY, Chen CL, Chuang LL, Cheng CH. Effects of whole body vibration on spasticity and lower extremity function in children with cerebral palsy. Hum Mov Sci. 2015 Feb;39:65-72. doi: 10.1016/j.humov.2014.11.003. Epub 2014 Nov 24.
- Background: PubMed 23445911Dickin DC, Faust KA, Wang H, Frame J. The acute effects of whole-body vibration on gait parameters in adults with cerebral palsy. J Musculoskelet Neuronal Interact. 2013 Mar;13(1):19-26.
- Background: PubMed 26032205Saquetto M, Carvalho V, Silva C, Conceicao C, Gomes-Neto M. The effects of whole body vibration on mobility and balance in children with cerebral palsy: a systematic review with meta-analysis. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):137-44.
- Background: PubMed 23477461Unger M, Jelsma J, Stark C. Effect of a trunk-targeted intervention using vibration on posture and gait in children with spastic type cerebral palsy: a randomized control trial. Dev Neurorehabil. 2013;16(2):79-88. doi: 10.3109/17518423.2012.715313.
- Background: PubMed 24388109Matute-Llorente A, Gonzalez-Aguero A, Gomez-Cabello A, Vicente-Rodriguez G, Casajus Mallen JA. Effect of whole-body vibration therapy on health-related physical fitness in children and adolescents with disabilities: a systematic review. J Adolesc Health. 2014 Apr;54(4):385-96. doi: 10.1016/j.jadohealth.2013.11.001. Epub 2014 Jan 1.
- Background: PubMed 18310204Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS, Benedict RE, Kirby RS, Durkin MS. Prevalence of cerebral palsy in 8-year-old children in three areas of the United States in 2002: a multisite collaboration. Pediatrics. 2008 Mar;121(3):547-54. doi: 10.1542/peds.2007-1270.
- 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.
Misbah Ghous, MSNMPT* 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 Group 1 Experimental group in people with Cerebral Palsy, Spastic, 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 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth (time frame: Change from Baseline spasticity to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087330, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.