- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04561349
Effects of TOT on Walking in Children With CP
Effects of Task Oriented Training on Walking in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan
- Armed forces Institute of Rehabilitation Medicine (AFIRM)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children with cognitive impairment
- Lower limb surgery in last 6 months
- Tetraplegic CP and who are unable to walk and follow command
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Task-oriented training (TOT)
Task-oriented training consisted of different functional tasks for lower limbs to improve balance and walk
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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
|
Active Comparator: Conventional rehabilitation treatment
Conventional rehabilitation treatment includes mat activities and range of motion (ROM) of all limbs, Lower limb strengthening and stretching, walking, cycling
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6th week
|
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
|
6th week
|
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. |
6th week
|
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.
|
6th week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Woollacott 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.
- Novak 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.
- 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.
- Granild-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.
- Novak 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. Erratum In: JAMA Pediatr. 2017 Sep 1;171(9):919.
- Pavone, 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.
- Rethlefsen 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.
- Kim, 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.
- Boyd 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.
- Paneth N. Establishing the diagnosis of cerebral palsy. Clin Obstet Gynecol. 2008 Dec;51(4):742-8. doi: 10.1097/GRF.0b013e318187081a.
- Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100.
- Ketelaar 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.
- Reid 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.
- Scrutton, D., Management of the motor disorders of children with cerebral palsy. 1984: Cambridge University Press.
- Brown, G.T. and S.A. Burns, The efficacy of neurodevelopmental treatment in paediatrics: a systematic review. British Journal of occupational therapy, 2001. 64(5): p. 235-244.
- Borggraefe I, Schaefer JS, Klaiber M, Dabrowski E, Ammann-Reiffer C, Knecht B, Berweck S, Heinen F, Meyer-Heim A. Robotic-assisted treadmill therapy improves walking and standing performance in children and adolescents with cerebral palsy. Eur J Paediatr Neurol. 2010 Nov;14(6):496-502. doi: 10.1016/j.ejpn.2010.01.002. Epub 2010 Feb 6.
- McGibbon NH, Andrade CK, Widener G, Cintas HL. Effect of an equine-movement therapy program on gait, energy expenditure, and motor function in children with spastic cerebral palsy: a pilot study. Dev Med Child Neurol. 1998 Nov;40(11):754-62. doi: 10.1111/j.1469-8749.1998.tb12344.x.
- Bumin G, Kayihan H. Effectiveness of two different sensory-integration programmes for children with spastic diplegic cerebral palsy. Disabil Rehabil. 2001 Jun 15;23(9):394-9. doi: 10.1080/09638280010008843.
- Lim H, Kim T. Effects of vojta therapy on gait of children with spastic diplegia. J Phys Ther Sci. 2013 Dec;25(12):1605-8. doi: 10.1589/jpts.25.1605. Epub 2014 Jan 8.
- Rensink M, Schuurmans M, Lindeman E, Hafsteinsdottir T. Task-oriented training in rehabilitation after stroke: systematic review. J Adv Nurs. 2009 Apr;65(4):737-54. doi: 10.1111/j.1365-2648.2008.04925.x. Epub 2009 Feb 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00242 Madiha Tariq
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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