Cerebral PalsyNCT06011616
Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy
A study testing Sensory training, Motor training and Conventional exercises in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study aims to determine the effects of upper limb sensorimotor training as compared to task oriented raining in subjects with cerebral palsy. The study will target the upperlimb functions using multiple outcomes and will find the changes in subjects undergoing sensorimotor or task oriented training. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Sensory training, Motor training and Conventional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Sep 2023to 25 Jan 2024
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hemiplegic cerebral palsy Modified Ashworth scale score 2 and 3
Who cannot join
- Other neurological disorders Previous upper limb surgeries Botox injection in last 1 year
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Alfarabi Special Education Centre/ Physical Health Centre
Islamabad, Islamabad, 44000
About this study
The study aims to determine the effects of upper limb sensorimotor training as compared to task oriented raining in subjects with cerebral palsy. The study will target the upperlimb functions using multiple outcomes and will find the changes in subjects undergoing sensorimotor or task oriented training.
Read the detailed description
The stduy will include subjects fulfilling the inclusion criteria, will be divided into 2 groups; interventional and control. The interventional group will be recieving sensorimotor training comprising of sensory activities and motor activities. The control group will be having motor activities in the form of task oriented training. The duration of intervention would be 40 minutes in each group, 3 days a week, for 8 weeks.
- Conditions
- Cerebral Palsy
- Being tested
- Sensory training, Motor training, Conventional exercises
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory trainingOther
sensory training includes superficial sensory and deep sensory activities i.e. play with dough, painting with finger, recognizing objects with blocked vision, recognizing the drawn figure on palm, oint compression, bearing the weight on the paretic hand, leaning on the paretic side, walking with hand, rolling the heavy objects, dough squeezing etc.
Motor trainingOther
Motor training would involve activitoes such as throwing and catching a ball, targeted ball throwing, hand in hand ball transferring, ball rolling, hitting a ball to ground and wall, hand roller etc.
Conventional exercisesOther
stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | Superficial and Deep Sensory training: 5 sets of 9 min, 3 times a week for 8 weeks.
Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks Receives: Other: Sensory training; Other: Motor training; Other: Conventional exercises |
| control group | Active comparator | Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks Receives: Other: Motor training; Other: Conventional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Measured: Baseline
Modified Ashworth Scale (MAS)
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Measured: After 4 weeks
Modified Ashworth Scale (MAS)
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Measured: After 8 weeks
Finger Joint Position Sense
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Measured: Baseline
Finger Joint Position Sense
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Measured: After 4 weeks
Finger Joint Position Sense
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Measured: After 8 weeks
Manual ability classification system
Manual ability classification system is used to determine daily use hand activities
Measured: Baseline
Manual ability classification system
Manual ability classification system is used to determine daily use hand activities
Measured: After 4 weeks
Manual ability classification system
Manual ability classification system is used to determine daily use hand activities
Measured: After 8 weeks
Manual Muscle Testing
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Measured: Baseline
Manual Muscle Testing
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Measured: After 4 weeks
Manual Muscle Testing
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Measured: After 8 weeks
Abilities of Hand (ABILHAND-KIDS)
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Measured: Baseline
Abilities of Hand (ABILHAND-KIDS)
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Measured: After 4 weeks
Abilities of Hand (ABILHAND-KIDS)
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Measured: After 8 weeks
Pediatric Arm Function Test
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Measured: Baseline
Pediatric Arm Function Test
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Measured: After 4 weeks
Pediatric Arm Function Test
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Measured: After 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start20 Sep 2023
- Primary completion20 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiran Khushnood, MSNMPT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011616
- Sponsor's protocol ID
- RIPHAH/FR&AHS/Letter-014194
- Status last verified
- Jan 2024
- First submitted
- 21 Aug 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06011616
- Acronym / sponsor ID
- RIPHAH/FR&AHS/Letter-014194
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 25 Aug 2023 (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.
The study aims to determine the effects of upper limb sensorimotor training as compared to task oriented raining in subjects with cerebral palsy. The study will target the upperlimb functions using multiple outcomes and will find the changes in subjects undergoing sensorimotor or task oriented training.
Detailed description
The stduy will include subjects fulfilling the inclusion criteria, will be divided into 2 groups; interventional and control. The interventional group will be recieving sensorimotor training comprising of sensory activities and motor activities. The control group will be having motor activities in the form of task oriented training. The duration of intervention would be 40 minutes in each group, 3 days a week, for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Other: Sensory training, Other: Motor training, Other: Conventional exercisesSuperficial and Deep Sensory training: 5 sets of 9 min, 3 times a week for 8 weeks. Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks |
| control group | Active comparator | Other: Motor training, Other: Conventional exercisesMotor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hemiplegic cerebral palsy Modified Ashworth scale score 2 and 3
Key exclusion criteria (1 listed)
- Other neurological disorders Previous upper limb surgeries Botox injection in last 1 year
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 |
|---|---|---|
| Sensory trainingsensory training includes superficial sensory and deep sensory activities i.e. play with dough, painting with finger, recognizing objects with blocked vision, recognizing the drawn figure on palm, oint compression, bearing the weight on the paretic hand, leaning on the paretic side, walking with hand, rolling the heavy objects, dough squeezing etc. | Other | interventional group |
| Motor trainingMotor training would involve activitoes such as throwing and catching a ball, targeted ball throwing, hand in hand ball transferring, ball rolling, hitting a ball to ground and wall, hand roller etc. | Other | control group, interventional group |
| Conventional exercisesstretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning | Other | control group, interventional group |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: Baseline
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Modified Ashworth Scale (MAS)
Time frame: After 4 weeks
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Modified Ashworth Scale (MAS)
Time frame: After 8 weeks
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Finger Joint Position Sense
Time frame: Baseline
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Finger Joint Position Sense
Time frame: After 4 weeks
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Finger Joint Position Sense
Time frame: After 8 weeks
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Manual ability classification system
Time frame: Baseline
Manual ability classification system is used to determine daily use hand activities
Manual ability classification system
Time frame: After 4 weeks
Manual ability classification system is used to determine daily use hand activities
Manual ability classification system
Time frame: After 8 weeks
Manual ability classification system is used to determine daily use hand activities
Manual Muscle Testing
Time frame: Baseline
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Manual Muscle Testing
Time frame: After 4 weeks
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Manual Muscle Testing
Time frame: After 8 weeks
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Abilities of Hand (ABILHAND-KIDS)
Time frame: Baseline
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Abilities of Hand (ABILHAND-KIDS)
Time frame: After 4 weeks
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Abilities of Hand (ABILHAND-KIDS)
Time frame: After 8 weeks
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Pediatric Arm Function Test
Time frame: Baseline
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Pediatric Arm Function Test
Time frame: After 4 weeks
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Pediatric Arm Function Test
Time frame: After 8 weeks
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
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 30 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiran Khushnood, MSNMPT study chair
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 Sensory training, Motor training and Conventional exercises in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Scale (MAS) (time frame: Baseline). The study lists 18 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 30 Jan 2024.