NCT04561349

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

September 17, 2020

Last Update Submit

September 22, 2020

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyWalkingTask oriented trainingConventional therapyBalance

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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.

    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.

    6th week

Study Arms (2)

Task-oriented training (TOT)

EXPERIMENTAL

Task-oriented training consisted of different functional tasks for lower limbs to improve balance and walk

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

Other: Conventional rehabilitation treatment

Interventions

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

Task-oriented training (TOT)
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.

Conventional rehabilitation treatment

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children with cognitive impairment
  • Lower limb surgery in last 6 months
  • Tetraplegic CP and who are unable to walk and follow command

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute of Rehabilitation Medicine (AFIRM)

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (22)

  • 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.

    PMID: 29637118BACKGROUND

  • 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.

    PMID: 25855100BACKGROUND

  • 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.

    PMID: 28715518BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16272660BACKGROUND

  • 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.

    PMID: 20868878BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 25131642BACKGROUND

  • 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.

    PMID: 23758951BACKGROUND

  • Paneth N. Establishing the diagnosis of cerebral palsy. Clin Obstet Gynecol. 2008 Dec;51(4):742-8. doi: 10.1097/GRF.0b013e318187081a.

    PMID: 18981799BACKGROUND

  • 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.

    PMID: 23045562BACKGROUND

  • Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100.

    PMID: 16417071BACKGROUND

  • 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.

    PMID: 11688590BACKGROUND

  • 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.

    PMID: 26077839BACKGROUND

  • 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.

    PMID: 16097489BACKGROUND

  • Scrutton, D., Management of the motor disorders of children with cerebral palsy. 1984: Cambridge University Press.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 20138788BACKGROUND

  • 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.

    PMID: 9881805BACKGROUND

  • 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.

    PMID: 11394590BACKGROUND

  • 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.

    PMID: 24409030BACKGROUND

  • 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.

    PMID: 19228241BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Nazish Rafique, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2020

First Posted

September 23, 2020

Study Start

June 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 30, 2019

Last Updated

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)