Cerebral PalsyNCT04561349
Effects of TOT on Walking in Children With CP
A study testing Task oriented training and Conventional rehabilitation treatment in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study was to determine the effects of task oriented training (TOT) on walking and balance in children with spastic Cerebral Palsy (CP). Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Task oriented training and Conventional rehabilitation treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2018to 30 Jan 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic CP children of age between 4 to 14 years
- With spasticity 2 or less on Modified Ashworth scale
- Who can walk (GMFCS level 1-3) and can
- Can perform different activities on command
Who cannot join
- Children with cognitive impairment
- Lower limb surgery in last 6 months
- Tetraplegic CP and who are unable to walk and follow command
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Rehabilitation Medicine (AFIRM)
Rawalpindi, Punjab Province
About this study
Official title: Effects of Task Oriented Training on Walking in Children With Cerebral Palsy
The purpose of the study was to determine the effects of task oriented training (TOT) on walking and balance in children with spastic Cerebral Palsy (CP).
Read the detailed description
The aim of study is to evaluate the effectiveness of task-oriented training on the walking in Cerebral Palsy children and compare its results with that of the conservative rehabilitation treatment. By training children to walk using task oriented training not only improves their walk and balance but also encourage them to actively participate in their own treatment process. Task oriented training approach can prove to be an effective technique for those CP children who can perform ambulation and have defined targets for gross motor activities
- Conditions
- Cerebral Palsy
- Being tested
- Task oriented training, Conventional rehabilitation treatment
- Keywords
- Cerebral Palsy, Walking, Task oriented training, Conventional therapy, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task oriented trainingOther
Task oriented training consisted of different functional tasks for lower limbs to improve balance and walk. Each task was given 5 minutes Tasks were progressed according to each child's performance. These progressions included increase of repetitions, speed and switching between the tasks. One hour practice of these tasks was advised for home plan
Conventional rehabilitation treatmentOther
Conventional rehabilitation treatment includes mat activities and ROM of all limbs, Lower limb strengthening and stretching, walking, cycling.
Each exercise was performed for 5 minutes. One hour practice of above exercises and thermotherapy for the spastic muscles advised for 10 minutes once a day at home was advised.
| Study group | Role | What they receive |
|---|---|---|
| Task-oriented training (TOT) | Experimental | Task-oriented training consisted of different functional tasks for lower limbs to improve balance and walk Receives: Other: Task oriented training |
| Conventional rehabilitation treatment | Active comparator | Conventional rehabilitation treatment includes mat activities and range of motion (ROM) of all limbs, Lower limb strengthening and stretching, walking, cycling Receives: Other: Conventional rehabilitation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go test (TUG)
A line was marked on floor at a distance at a distance of 3 meters (9.8 feet) leveled walking. A score of 30 seconds or more suggests that the person may be prone to falls. Alternatively, a recommended practical cut-off value for the TUG to indicate normal versus below normal performance is 12 seconds.
Measured: 6th week
Functional Walking Test (FWT)
The purpose of function walk test is to evaluate the walking balance and functional walking ability of a child. It has 5 main components. With different scores each, that is 3, 2 and 1. Also it specifies if there is any asymmetry between Right and Left lower limb and better limb functioning is recorded. Total score of FWT is 23 points
Measured: 6th week
Modified Ashworth scale (MAS)
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.
A score of 1 indicates no resistance, and 5 indicates rigidity.
Measured: 6th week
Gross Motor Function Classification System (GMFCS)
GMFCS divides the CP children into 5 levels, where level 1 is the least affected and most functional children and level 5 most affected and least functional.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Jun 2018
- Primary completion1 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazish Rafique, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561349
- Sponsor's protocol ID
- REC/00242 Madiha Tariq
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toovey R, Bernie C, Harvey AR, McGinley JL, Spittle AJ. Task-specific gross motor skills training for ambulant school-aged children with cerebral palsy: a systematic review. BMJ Paediatr Open. 2017 Aug 11;1(1):e000078. doi: 10.1136/bmjpo-2017-000078. eCollection 2017.
PubMed 29637118Granild-Jensen JB, Rackauskaite G, Flachs EM, Uldall P. Predictors for early diagnosis of cerebral palsy from national registry data. Dev Med Child Neurol. 2015 Oct;57(10):931-5. doi: 10.1111/dmcn.12760. Epub 2015 Apr 9.
PubMed 25855100Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
PubMed 28715518Pavone, V. and G. Testa, Classification of cerebral Palsy. Orthopedic Management of Children with Cerebral Palsy. A Comprehensive Approach, eds F. Canavese, and J. Deslandes (New York, NY: NOVA), 2015: p. 75-98.
Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.
PubMed 16272660Rethlefsen SA, Ryan DD, Kay RM. Classification systems in cerebral palsy. Orthop Clin North Am. 2010 Oct;41(4):457-67. doi: 10.1016/j.ocl.2010.06.005.
PubMed 20868878Kim, J.-H. and Y.-E. Choi, The Effect of Task-oriented Training on Mobility Function, Postural Stability in Children with Cerebral Palsy. Korean Society of Physical Medicine, 2017. 12(3): p. 79-84.
Schiariti V, Selb M, Cieza A, O'Donnell M. International Classification of Functioning, Disability and Health Core Sets for children and youth with cerebral palsy: a consensus meeting. Dev Med Child Neurol. 2015 Feb;57(2):149-58. doi: 10.1111/dmcn.12551. Epub 2014 Aug 6.
PubMed 25131642Boyd RN, Jordan R, Pareezer L, Moodie A, Finn C, Luther B, Arnfield E, Pym A, Craven A, Beall P, Weir K, Kentish M, Wynter M, Ware R, Fahey M, Rawicki B, McKinlay L, Guzzetta A. Australian Cerebral Palsy Child Study: protocol of a prospective population based study of motor and brain development of preschool aged children with cerebral palsy. BMC Neurol. 2013 Jun 11;13:57. doi: 10.1186/1471-2377-13-57.
PubMed 23758951Paneth N. Establishing the diagnosis of cerebral palsy. Clin Obstet Gynecol. 2008 Dec;51(4):742-8. doi: 10.1097/GRF.0b013e318187081a.
PubMed 18981799Novak I, Hines M, Goldsmith S, Barclay R. Clinical prognostic messages from a systematic review on cerebral palsy. Pediatrics. 2012 Nov;130(5):e1285-312. doi: 10.1542/peds.2012-0924. Epub 2012 Oct 8.
PubMed 23045562Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100.
PubMed 16417071Ketelaar M, Vermeer A, Hart H, van Petegem-van Beek E, Helders PJ. Effects of a functional therapy program on motor abilities of children with cerebral palsy. Phys Ther. 2001 Sep;81(9):1534-45. doi: 10.1093/ptj/81.9.1534.
PubMed 11688590Reid LB, Rose SE, Boyd RN. Rehabilitation and neuroplasticity in children with unilateral cerebral palsy. Nat Rev Neurol. 2015 Jul;11(7):390-400. doi: 10.1038/nrneurol.2015.97. Epub 2015 Jun 16.
PubMed 26077839Woollacott MH, Shumway-Cook A. Postural dysfunction during standing and walking in children with cerebral palsy: what are the underlying problems and what new therapies might improve balance? Neural Plast. 2005;12(2-3):211-9; discussion 263-72. doi: 10.1155/NP.2005.211.
PubMed 16097489
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task Oriented Training on Walking in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04561349
- Acronym / sponsor ID
- REC/00242 Madiha Tariq
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Walking, Task oriented training, Conventional therapy, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 23 Sep 2020 (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 purpose of the study was to determine the effects of task oriented training (TOT) on walking and balance in children with spastic Cerebral Palsy (CP).
Detailed description
The aim of study is to evaluate the effectiveness of task-oriented training on the walking in Cerebral Palsy children and compare its results with that of the conservative rehabilitation treatment. By training children to walk using task oriented training not only improves their walk and balance but also encourage them to actively participate in their own treatment process. Task oriented training approach can prove to be an effective technique for those CP children who can perform ambulation and have defined targets for gross motor activities
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-oriented training (TOT) | Experimental | Other: Task oriented trainingTask-oriented training consisted of different functional tasks for lower limbs to improve balance and walk |
| Conventional rehabilitation treatment | Active comparator | Other: Conventional rehabilitation treatmentConventional rehabilitation treatment includes mat activities and range of motion (ROM) of all limbs, Lower limb strengthening and stretching, walking, cycling |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Spastic CP children of age between 4 to 14 years
- With spasticity 2 or less on Modified Ashworth scale
- Who can walk (GMFCS level 1-3) and can
- Can perform different activities on command
Key exclusion criteria (3 listed)
- Children with cognitive impairment
- Lower limb surgery in last 6 months
- Tetraplegic CP and who are unable to walk and follow command
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 |
|---|---|---|
| Task oriented trainingTask oriented training consisted of different functional tasks for lower limbs to improve balance and walk. Each task was given 5 minutes Tasks were progressed according to each child's performance. These progressions included increase of repetitions, speed and switching between the tasks. One hour practice of these tasks was advised for home plan | Other | Task-oriented training (TOT) |
| Conventional rehabilitation treatmentConventional rehabilitation treatment includes mat activities and ROM of all limbs, Lower limb strengthening and stretching, walking, cycling. Each exercise was performed for 5 minutes. One hour practice of above exercises and thermotherapy for the spastic muscles advised for 10 minutes once a day at home was advised. | Other | Conventional rehabilitation treatment |
Primary outcome
Timed Up and Go test (TUG)
Time frame: 6th week
A line was marked on floor at a distance at a distance of 3 meters (9.8 feet) leveled walking. A score of 30 seconds or more suggests that the person may be prone to falls. Alternatively, a recommended practical cut-off value for the TUG to indicate normal versus below normal performance is 12 seconds.
Functional Walking Test (FWT)
Time frame: 6th week
The purpose of function walk test is to evaluate the walking balance and functional walking ability of a child. It has 5 main components. With different scores each, that is 3, 2 and 1. Also it specifies if there is any asymmetry between Right and Left lower limb and better limb functioning is recorded. Total score of FWT is 23 points
Modified Ashworth scale (MAS)
Time frame: 6th week
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform. A score of 1 indicates no resistance, and 5 indicates rigidity.
Gross Motor Function Classification System (GMFCS)
Time frame: 6th week
GMFCS divides the CP children into 5 levels, where level 1 is the least affected and most functional children and level 5 most affected and least functional.
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 23 Sep 2020.
- Background: PubMed 29637118Toovey R, Bernie C, Harvey AR, McGinley JL, Spittle AJ. Task-specific gross motor skills training for ambulant school-aged children with cerebral palsy: a systematic review. BMJ Paediatr Open. 2017 Aug 11;1(1):e000078. doi: 10.1136/bmjpo-2017-000078. eCollection 2017.
- Background: PubMed 25855100Granild-Jensen JB, Rackauskaite G, Flachs EM, Uldall P. Predictors for early diagnosis of cerebral palsy from national registry data. Dev Med Child Neurol. 2015 Oct;57(10):931-5. doi: 10.1111/dmcn.12760. Epub 2015 Apr 9.
- Background: PubMed 28715518Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
- BackgroundPavone, V. and G. Testa, Classification of cerebral Palsy. Orthopedic Management of Children with Cerebral Palsy. A Comprehensive Approach, eds F. Canavese, and J. Deslandes (New York, NY: NOVA), 2015: p. 75-98.
- Background: PubMed 16272660Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.
- Background: PubMed 20868878Rethlefsen SA, Ryan DD, Kay RM. Classification systems in cerebral palsy. Orthop Clin North Am. 2010 Oct;41(4):457-67. doi: 10.1016/j.ocl.2010.06.005.
- BackgroundKim, J.-H. and Y.-E. Choi, The Effect of Task-oriented Training on Mobility Function, Postural Stability in Children with Cerebral Palsy. Korean Society of Physical Medicine, 2017. 12(3): p. 79-84.
- Background: PubMed 25131642Schiariti V, Selb M, Cieza A, O'Donnell M. International Classification of Functioning, Disability and Health Core Sets for children and youth with cerebral palsy: a consensus meeting. Dev Med Child Neurol. 2015 Feb;57(2):149-58. doi: 10.1111/dmcn.12551. Epub 2014 Aug 6.
- Background: PubMed 23758951Boyd RN, Jordan R, Pareezer L, Moodie A, Finn C, Luther B, Arnfield E, Pym A, Craven A, Beall P, Weir K, Kentish M, Wynter M, Ware R, Fahey M, Rawicki B, McKinlay L, Guzzetta A. Australian Cerebral Palsy Child Study: protocol of a prospective population based study of motor and brain development of preschool aged children with cerebral palsy. BMC Neurol. 2013 Jun 11;13:57. doi: 10.1186/1471-2377-13-57.
- Background: PubMed 18981799Paneth N. Establishing the diagnosis of cerebral palsy. Clin Obstet Gynecol. 2008 Dec;51(4):742-8. doi: 10.1097/GRF.0b013e318187081a.
- Background: PubMed 23045562Novak I, Hines M, Goldsmith S, Barclay R. Clinical prognostic messages from a systematic review on cerebral palsy. Pediatrics. 2012 Nov;130(5):e1285-312. doi: 10.1542/peds.2012-0924. Epub 2012 Oct 8.
- Background: PubMed 16417071Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100.
- 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.
Nazish Rafique, MSPT 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 Task oriented training and Conventional rehabilitation treatment 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 4 inclusion and 3 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 23 Sep 2020. 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?
Timed Up and Go test (TUG) (time frame: 6th week). The study lists 4 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 NCT04561349, which also lists 22 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 23 Sep 2020.