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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05962749
Other study ID # 2023-743
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 20, 2023
Est. completion date December 29, 2023

Study information

Verified date July 2023
Source Alanya Alaaddin Keykubat University
Contact Ebru Keklikci
Phone +90 242 510 61 45
Email ebru.keklikci@alanya.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cerebral palsy (CP) is defined as a disorder of the developing brain that causes movement disorders and may be associated with other neurologically based disorders. Gait abnormalities are a direct result of damage to the motor areas of the brain and include symptoms such as spasticity, dystonia, weakness, loss of selective muscle control, dependence on primitive reflexes, abnormal muscle and inadequate balance reactions. Walking backwards during activities of daily living is as important as walking forward. Some of these activities are stepping back towards the chair, stepping back when opening the door and pulling the door, reflexively leaning back when suddenly encountering an obstacle or uneven ground. In addition, backward walking is defined as a more complex activity that requires more neuromuscular control, proprioception sense, and protective reflex activation than forward walking. Selective motor control is an essential part of typical human movement, allowing for smooth and discrete control of joint movement. Impaired selective motor control causes abnormal reciprocal muscle activations or involuntary combined movements, leading to difficulties with coordination, balance, walking efficiency, and symmetry. Impaired selective motor control is associated with poor gross motor function and balance control, severe general gait deviations, and decreased walking speed. The aim of this study is to examine the relationship between forward and backward walking and selective motor control, trunk control and balance in children with cerebral palsy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date December 29, 2023
Est. primary completion date December 29, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - To be diagnosed with cerebral palsy by a specialist physician - Gross Motor Function Classification System (GMFCS) level I or II - Children with lower extremity muscles level = 2 according to the Modified Ashworth Scale (MAS) - Ability to follow verbal commands - Modified Ashworth Scale (MAS) Level =2 - Complete passive range of motion in the ankle and knee joints - Agree to participate in the study (with parent and child consent) Exclusion Criteria: - Having had Botox (Botulinum toxin) or a surgical operation in the last 6 months - Having contractures in the ankle and knee joints that affect walking

Study Design


Intervention

Other:
Assessment
3 meter backward walk test (3MBWT), 10 meter walk test (10MWT), Selective Control Assessment of the Lower Extremities (SCALE), Trunk Control Measurement Scale (TCMS), Pediatric Balance Scale (PBS), Functional Independence Measure for Children (WeeFIM), Modified Ashworth Scale (MAS)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alanya Alaaddin Keykubat University

References & Publications (7)

Cahill-Rowley K, Rose J. Etiology of impaired selective motor control: emerging evidence and its implications for research and treatment in cerebral palsy. Dev Med Child Neurol. 2014 Jun;56(6):522-8. doi: 10.1111/dmcn.12355. Epub 2013 Dec 21. — View Citation

Fowler EG, Goldberg EJ. The effect of lower extremity selective voluntary motor control on interjoint coordination during gait in children with spastic diplegic cerebral palsy. Gait Posture. 2009 Jan;29(1):102-7. doi: 10.1016/j.gaitpost.2008.07.007. Epub — View Citation

Gage JR, Novacheck TF. An update on the treatment of gait problems in cerebral palsy. J Pediatr Orthop B. 2001 Oct;10(4):265-74. — View Citation

Raffegeau TE, Kellaher GK, Terza MJ, Roper JA, Altmann LJ, Hass CJ. Older women take shorter steps during backwards walking and obstacle crossing. Exp Gerontol. 2019 Jul 15;122:60-66. doi: 10.1016/j.exger.2019.04.011. Epub 2019 Apr 26. — View Citation

Rumberg F, Bakir MS, Taylor WR, Haberl H, Sarpong A, Sharankou I, Lebek S, Funk JF. The Effects of Selective Dorsal Rhizotomy on Balance and Symmetry of Gait in Children with Cerebral Palsy. PLoS One. 2016 Apr 4;11(4):e0152930. doi: 10.1371/journal.pone.0 — View Citation

Teo TWL, Mong Y, Ng SSM (2013) The repetitive Five-Times-Sit-To-Stand test: its reliability in older adults. Int J Ther Rehabil 20(3):122-130

Yun G, Huang M, Cao J, Hu X. Selective motor control correlates with gross motor ability, functional balance and gait performance in ambulant children with bilateral spastic cerebral palsy. Gait Posture. 2023 Jan;99:9-13. doi: 10.1016/j.gaitpost.2022.10.0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 3 meter backward walk test (3MBWT) First day
Primary 10 meter walk test (10MWT) First day
Secondary Selective Control Assessment of the Lower Extremities (SCALE) First day
Secondary Trunk Control Measurement Scale (TCMS) First day
Secondary Pediatric Balance Scale (PBS) First day
Secondary Functional Independence Measure for Children (WeeFIM) First day
Secondary Modified Ashworth Scale (MAS) First day
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