The Effect of Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Cerebral Palsy

NCT03191552 | Completed Results DMC

• 1 other identifier: 09.2013.0351
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effects and feasibility of lycra based compression garment called Stabilizing Pressure Input Orthosis (SPIO) vest on posture and balance during sitting and gross manuel dexterity, parent satisfaction with the garment and to to compare 2 hours vs 6 hours of daily wear time.

Conditions

Cerebral Palsy; Postural; Defect

Keywords

Cerebral palsy; lycra garments; orthosis; suit therapy; trunk control

Outcome Measures

Primary Outcomes (4)

• Sitting Assessment Scale

  Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively.

  Immediate after orthosis is worn

• Sitting Assessment Scale

  Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively

  2 weeks

• Sitting Assessment Scale

  Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively

  1 month

• Sitting Assessment Scale

  Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively

  3 months

Secondary Outcomes (13)

• Gross Motor Function Measure-B, Sitting Dimension

  2 weeks

• Gross Motor Function Measure-B, Sitting Dimension

  1 month

• Gross Motor Function Measure-B, Sitting Dimension

  3 months

• Box and Block Test (BBT)

  Immediate after orthosis is worn

• Box and Block Test (BBT)

  2 weeks

Study Arms (3)

SPIO 2 hours

EXPERIMENTAL

All children will be hospitalized for 2 weeks and will receive conventional exercise therapy including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks 2 hours a day. SPIO 2 hours group will receive conventional exercise therapy with the garment on for 2 hours.

Device: SPIO; Other: conventional exercises

SPIO 6 hours

EXPERIMENTAL

SPIO 6 hours group will receive conventional exercise therapy with the garment on for 2 hours and worn SPIO 4 hours more in addition to 2 hour of wear during exercise therapy.

Device: SPIO; Other: conventional exercises

Control(conventional exercises)

ACTIVE COMPARATOR

Control group will only receive conventional exercise therapy (for two hours a day) including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks

Other: conventional exercises

Interventions

SPIO DEVICE

SPIO (stabilizing input pressure orthosis) 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy. SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy. (conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills

SPIO 2 hours; SPIO 6 hours

conventional exercises OTHER

range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills

Control(conventional exercises); SPIO 2 hours; SPIO 6 hours

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• being classified at Gross Motor Function Classification System (GMFCS) level III-IV
• being classified at Manual Ability Classification System (MACS) level III-IV
• being able to understand and execute given instructions for evaluations
• parental acceptance of using the lycra based compression garment.

You may not qualify if:

• serious respiratory restriction
• having refractory cyanosis or circulatory disorder
• having undergone lycra compression orthosis treatment programme previously
• having undergone botulinum toxin injection within last 3 months or orthopedic surgery within 1 year
• severe scoliosis (Cobb angle (CA) \>40°)
• uncontrolled epilepsy
• having intrathecal baclofen pump
• having undergone selective dorsal rhizotomy
• having reflux more than 3 times a week.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (11)

• Blair E, Ballantyne J, Horsman S, Chauvel P. A study of a dynamic proximal stability splint in the management of children with cerebral palsy. Dev Med Child Neurol. 1995 Jun;37(6):544-54. doi: 10.1111/j.1469-8749.1995.tb12041.x.

  PMID: 7789663 RESULT

• How does the TherSuit® works? TheraSuit® / TheraSuit Method®. http://www.suittherapy.com/therasuit%20info.htm.

  RESULT

• Hylton N, Schoos KK. Deep Pressure Sensory Input. SPIO Flexible Compression Bracing. http://www.spioworks.com/files/Deep%20Pressure%20Sensory%20Input%20Hylton%20Schoos.pdf; 2007.

  RESULT

• Christy JB, Steed L. Commentary on "The effect of suit wear during an intensive therapy program in children with cerebral palsy". Pediatr Phys Ther. 2011 Summer;23(2):143. doi: 10.1097/PEP.0b013e318219352d. No abstract available.

  PMID: 21552074 RESULT

• Hylton N, Allen C. The development and use of SPIO Lycra compression bracing in children with neuromotor deficits. Pediatr Rehabil. 1997 Apr-Jun;1(2):109-16. doi: 10.3109/17518429709025853.

  PMID: 9689245 RESULT

• Knox V. The use of Lycra garments in children with cerebral palsy: A report of a descriptive clinical trial. The British Journal of Occupational Therapy 2003; 66: 71-7.

  RESULT

• Matthews M, Crawford R. The use of dynamic Lycra orthosis in the treatment of scoliosis: a case study. Prosthet Orthot Int. 2006 Aug;30(2):174-81. doi: 10.1080/03093640600794668.

  PMID: 16990228 RESULT

• Saavedra S. Trunk control in cerebral palsy: are we ready to address the elephant in the room? Dev Med Child Neurol. 2015 Apr;57(4):309-10. doi: 10.1111/dmcn.12614. Epub 2014 Nov 20. No abstract available.

  PMID: 25412796 RESULT

• Myhr U, von Wendt L. Improvement of functional sitting position for children with cerebral palsy. Dev Med Child Neurol. 1991 Mar;33(3):246-56. doi: 10.1111/j.1469-8749.1991.tb05114.x.

  PMID: 1760002 RESULT

• Myhr U, von Wendt L, Norrlin S, Radell U. Five-year follow-up of functional sitting position in children with cerebral palsy. Dev Med Child Neurol. 1995 Jul;37(7):587-96. doi: 10.1111/j.1469-8749.1995.tb12047.x.

  PMID: 7615145 RESULT

• Giray E, Karadag-Saygi E, Ozsoy T, Gungor S, Kayhan O. The effects of vest type dynamic elastomeric fabric orthosis on sitting balance and gross manual dexterity in children with cerebral palsy: a single-blinded randomised controlled study. Disabil Rehabil. 2020 Feb;42(3):410-418. doi: 10.1080/09638288.2018.1501098. Epub 2018 Oct 7.

  PMID: 30293457 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Outcome measures assesses body structure and function only. Effects of orthosis on activity and participation were not evaluated

Results Point of Contact

• Title: Esra Giray
• Organization: Department of Physical medicine and Rehabilitation, Marmara University School of Medicine, Istanbul,Turkey

girayesra@hotmail.com

+90216624545

Study Officials

• Esra Giray, MD

  Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Naime Evrim Karadag-Saygi, Prof

  Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Observational Model: Cohort Time Perspective: Prospective Randomized controlled trial

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 19, 2017
• Study Start: June 20, 2017
• Primary Completion: August 20, 2017
• Study Completion: September 20, 2017
• Last Updated: January 19, 2018
• Results First Posted: December 14, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)