Hemiplegic Cerebral PalsyNCT05252169
Proprioceptive Training,Balance,Motor Function,Spastic Cerebral Palsy Patient
A study testing Proprioceptive training and Routine Physical therapy in people with Hemiplegic Cerebral Palsy, run by University of Lahore at 1 site in Pakistan.
Trial summary
Study Design: Randomized Controlled Trial Settings: Study will be conducted at Mobility quest clinic, Lahore Sample size:37 in each group Control group receive : Routine physical therapy Experimental group receive : Routine physical therapy+proprioceptive training Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Proprioceptive training and Routine Physical therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Dec 2021to 26 Aug 2022
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Children with spastic hemiplegic cerebral palsy ranging from 8 to 14 years. 19
- Both genders.
- Gross motor function level II.
- Children who can follow commands.
- Pre-diagnosed cerebral palsy subjects of cerebral palsy confirmed by an expert pediatrician.
Who cannot join
- • The children with cerebral palsy having co-morbid conditions and contractures that can interfere with recovery will be excluded.
- The children having severe mental retardation because of difficulty in understanding commands.
- Any red flag signs (tumor, fracture, metabolic diseases, prolong history of steroidal use.
- Patients having ventriculoperitonel shunt.
- Patients unable to travel frequently or as per call from rehab center.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Mobility Quest Clinic
Lahore, Punjab Province, 38000
Dr Waqar Afzal, Phd*, 03214668377, waqar.afzal@uipt.uol.edu.pk
About this study
Official title: Effects of Proprioceptive Training on Balance and Motor Function in Children With Spastic Hemiplegic Cerebral Palsy
Study Design: Randomized Controlled Trial Settings: Study will be conducted at Mobility quest clinic, Lahore Sample size:37 in each group Control group receive : Routine physical therapy Experimental group receive : Routine physical therapy+proprioceptive training
Read the detailed description
Control group : Group A will be control group which will be of 60 minutes each session. The routine physical therapy will include
- Passive stretching exercises
- Weight bearing exercises
- Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes.
Experimental group : Routine physical therapy+proprioceptive training. Group B will be given proprioceptive training. Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes each session.
The Proprioceptive training included the following exercises.
- Stair climbing up and down (a regular 3 steps staircase).
- Standing with feet approximately shoulder-width apart and arms extended out slightly forward lower than the shoulder, then lifting both heel off the floor and to hold the position for 10 seconds, followed by climbing regular steps staircase. This procedure will be performed with eyes closed also.
- Standing with feet side by side \& holding the arms in same position as described above, one foot is placed on the inside of the opposing ankle and to hold the position for 10 seconds. Followed by climbing regular steps staircase. This procedure will be performed will be eyes closed also.
- To perform one leg standing with one foot raised to the back and to maintain the position for minimum 3 seconds. This procedure will be performed with eyes closed also.
- Same exercise as above performed but with one foot raised to the front. This procedure will be then performed with eyes closed.
- Walking heel to toes.
- Rising from a standard chair (4 times) without arm support. For proprioception Swiss ball will be use as a modality and it will be performed passively by the physical therapist.For this physical therapist will be on the front of the subject different activities will be performed in different positions.
- For posture control development child will sit on the ball and ball will be rolled from side to side.
- Extension rotation and flexion rotation will be performed to facilitate trunk rotation.
- Trunk rotation will be performed with stabilized pelvis and hip. Reaching activities will be done in different directions that will allow the child to work on trunk and lateral weight shifting.
- Position the child supine on the ball with the feet to the floor. Hold through the lower abdominals to stabilize them on to the ball. Now facilitate through one arm and bring the child diagonally up to stance.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Proprioceptive training, Routine Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive trainingOther
Also called Routine physical therapy
Proprioceptive Training will include some active exercises such as stair climbing up and down,one leg standing,Walking heel to toes,rising from a standard chair.
And swiss ball training will be applied passively by therapist in which child will sit on the ball and ball will be rolled from side to side,Extension rotation and flexion rotation will be performed to facilitate trunk rotation,Trunk rotation will be performed with stabilized pelvis and hip.
Routine Physical therapyOther
Group A will be given routine physical therapy which will be of 60 minutes each session. The routine physical therapy will include
- Passive stretching exercises
- Weight bearing exercises
- Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Training | Experimental | Proprioceptive training will include : Stair climbing up and down,Standing with feet side by side and up and down,one leg standing,Walking heel to toes,Rising from a standard chair.
Swiss ball activity will be performed passively by the physical therapist in which child will sit on the ball and ball will be rolled from side to side,Extension rotation and flexion rotation will be performed to facilitate trunk rotation that will be performed with stabilized pelvis and hip.
Routine physical therapy will include passive stretching ,strength training and weight bearing exercises. total session will be of 60 minutes. Receives: Other: Proprioceptive training; Other: Routine Physical therapy |
| Routine Physical Therapy | Placebo comparator | Group A will be given routine physical therapy which will be of 60 minutes each session. The routine physical therapy will include
* Passive stretching exercises
* Weight bearing exercises
* Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes. Receives: Other: Routine Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
balance will be measured by pediatric balance scale.The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: 12 weeks
Motor Function
Motor function will be measured by Gross Motor Function Measure 88 scale.It includes scoring key in which 0 means does not initiate and 3 means completely performs the exercise.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start23 Dec 2021
- Primary completion16 Aug 2022 (estimated)
- Study completion26 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kinza Amin, MSPTN*, Principal investigator, Univerity of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252169
- Sponsor's protocol ID
- IRB-UOL-FAHS/1079/2021
- Status last verified
- Feb 2022
- First submitted
- 12 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown KE, Neva JL, Ledwell NM, Boyd LA. Use of transcranial magnetic stimulation in the treatment of selected movement disorders. Degener Neurol Neuromuscul Dis. 2014 Dec 4;4:133-151. doi: 10.2147/DNND.S70079. eCollection 2014.
PubMed 32669907Newbury DF, Simpson NH, Thompson PA, Bishop DVM. Stage 2 Registered Report: Variation in neurodevelopmental outcomes in children with sex chromosome trisomies: testing the double hit hypothesis. Wellcome Open Res. 2021 Jun 1;3:85. doi: 10.12688/wellcomeopenres.14677.4. eCollection 2018.
PubMed 30271887Uwizeye D, Karimi F, Thiong'o C, Syonguvi J, Ochieng V, Kiroro F, Gateri A, Khisa AM, Wao H. Factors associated with research productivity in higher education institutions in Africa: a systematic review. AAS Open Res. 2022 Jan 28;4:26. doi: 10.12688/aasopenres.13211.2. eCollection 2021.
PubMed 34368619Ozyurek T, Demiryurek EO. Comparison of the Effectiveness of Different Techniques for Supportive Removal of Root Canal Filling Material. Eur Endod J. 2016 Dec 26;1(1):1-6. doi: 10.5152/eej.2016.16002. eCollection 2016.
PubMed 32566900
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Training on Balance and Motor Function in Children With Spastic Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05252169
- Acronym / sponsor ID
- IRB-UOL-FAHS/1079/2021
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 16 Aug 2022 (estimated)
- Study completion
- 26 Aug 2022 (estimated)
- First posted
- 23 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.
Study Design: Randomized Controlled Trial Settings: Study will be conducted at Mobility quest clinic, Lahore Sample size:37 in each group Control group receive : Routine physical therapy Experimental group receive : Routine physical therapy+proprioceptive training
Detailed description
Control group : Group A will be control group which will be of 60 minutes each session. The routine physical therapy will include
- Passive stretching exercises
- Weight bearing exercises
- Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes.
Experimental group : Routine physical therapy+proprioceptive training. Group B will be given proprioceptive training. Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes each session.
The Proprioceptive training included the following exercises.
- Stair climbing up and down (a regular 3 steps staircase).
- Standing with feet approximately shoulder-width apart and arms extended out slightly forward lower than the shoulder, then lifting both heel off the floor and to hold the position for 10 seconds, followed by climbing regular steps staircase. This procedure will be performed with eyes closed also.
- Standing with feet side by side \& holding the arms in same position as described above, one foot is placed on the inside of the opposing ankle and to hold the position for 10 seconds. Followed by climbing regular steps staircase. This procedure will be performed will be eyes closed also.
- To perform one leg standing with one foot raised to the back and to maintain the position for minimum 3 seconds. This procedure will be performed with eyes closed also.
- Same exercise as above performed but with one foot raised to the front. This procedure will be then performed with eyes closed.
- Walking heel to toes.
- Rising from a standard chair (4 times) without arm support. For proprioception Swiss ball will be use as a modality and it will be performed passively by the physical therapist.For this physical therapist will be on the front of the subject different activities will be performed in different positions.
- For posture control development child will sit on the ball and ball will be rolled from side to side.
- Extension rotation and flexion rotation will be performed to facilitate trunk rotation.
- Trunk rotation will be performed with stabilized pelvis and hip. Reaching activities will be done in different directions that will allow the child to work on trunk and lateral weight shifting.
- Position the child supine on the ball with the feet to the floor. Hold through the lower abdominals to stabilize them on to the ball. Now facilitate through one arm and bring the child diagonally up to stance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Training | Experimental | Other: Proprioceptive training, Other: Routine Physical therapyProprioceptive training will include : Stair climbing up and down,Standing with feet side by side and up and down,one leg standing,Walking heel to toes,Rising from a standard chair. Swiss ball activity will be performed passively by the physical therapist in which child will sit on the ball and ball will be rolled from side to side,Extension rotation and flexion rotation will be performed to facilitate trunk rotation that will be performed with stabilized pelvis and hip. Routine physical therapy will include passive stretching ,strength training and weight bearing exercises. total session will be of 60 minutes. |
| Routine Physical Therapy | Placebo comparator | Other: Routine Physical therapyGroup A will be given routine physical therapy which will be of 60 minutes each session. The routine physical therapy will include * Passive stretching exercises * Weight bearing exercises * Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Children with spastic hemiplegic cerebral palsy ranging from 8 to 14 years. 19
Key exclusion criteria (5 listed)
- • The children with cerebral palsy having co-morbid conditions and contractures that can interfere with recovery will be excluded.
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 |
|---|---|---|
| Proprioceptive trainingAlso: Routine physical therapyProprioceptive Training will include some active exercises such as stair climbing up and down,one leg standing,Walking heel to toes,rising from a standard chair. And swiss ball training will be applied passively by therapist in which child will sit on the ball and ball will be rolled from side to side,Extension rotation and flexion rotation will be performed to facilitate trunk rotation,Trunk rotation will be performed with stabilized pelvis and hip. | Other | Proprioceptive Training |
| Routine Physical therapyGroup A will be given routine physical therapy which will be of 60 minutes each session. The routine physical therapy will include * Passive stretching exercises * Weight bearing exercises * Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes. | Other | Proprioceptive Training, Routine Physical Therapy |
Primary outcome
Balance
Time frame: 12 weeks
balance will be measured by pediatric balance scale.The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Motor Function
Time frame: 12 weeks
Motor function will be measured by Gross Motor Function Measure 88 scale.It includes scoring key in which 0 means does not initiate and 3 means completely performs the exercise.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 32669907Brown KE, Neva JL, Ledwell NM, Boyd LA. Use of transcranial magnetic stimulation in the treatment of selected movement disorders. Degener Neurol Neuromuscul Dis. 2014 Dec 4;4:133-151. doi: 10.2147/DNND.S70079. eCollection 2014.
- Background: PubMed 30271887Newbury DF, Simpson NH, Thompson PA, Bishop DVM. Stage 2 Registered Report: Variation in neurodevelopmental outcomes in children with sex chromosome trisomies: testing the double hit hypothesis. Wellcome Open Res. 2021 Jun 1;3:85. doi: 10.12688/wellcomeopenres.14677.4. eCollection 2018.
- Background: PubMed 34368619Uwizeye D, Karimi F, Thiong'o C, Syonguvi J, Ochieng V, Kiroro F, Gateri A, Khisa AM, Wao H. Factors associated with research productivity in higher education institutions in Africa: a systematic review. AAS Open Res. 2022 Jan 28;4:26. doi: 10.12688/aasopenres.13211.2. eCollection 2021.
- Background: PubMed 32566900Ozyurek T, Demiryurek EO. Comparison of the Effectiveness of Different Techniques for Supportive Removal of Root Canal Filling Material. Eur Endod J. 2016 Dec 26;1(1):1-6. doi: 10.5152/eej.2016.16002. eCollection 2016.
- 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.
Kinza Amin, MSPTN* principal investigator
Univerity of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive training and Routine Physical therapy in people with Hemiplegic Cerebral Palsy, run by University of Lahore 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Mar 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Haider Ullah Khan, MSPTN (03314127210, haiderullah@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 12 weeks). The study lists 2 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 NCT05252169, which also lists 4 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 17 Mar 2022.