NCT06198127

Brief Summary

Cerebral Palsy (CP) is a motor disorder caused by damage to the brain that affects posture, movement, and muscle control. It can lead to difficulties with trunk control, gait, and posture, which can impact daily activities and quality of life. Core stability exercises have been shown to improve trunk control, gait, and posture in children with CP by improving muscle activation patterns and enhancing postural stability. Kinesio-taping, on the other hand, is a therapeutic technique that involves the application of a stretchy tape to the skin to provide support, stability, and pain relief to the muscles and joints. It has been proposed that kinesio-taping may enhance the effects of exercises by providing additional support and proprioceptive feedback. This will be randomized controlled trial study. Sampling technique will be non-probability convenience sampling. Computer randomization will be used to locate subjects in two groups. After that informed consent will be taken and patients will be included in the study based on the inclusion criteria. Study will be conducted in 22 CP children age 7-12 years, ability to stand and walk, ability to follow instructions and assess by assessment tools as GMFCS level II, GARS, TIS and PAS pre and post intervention. Study groups will be divided into 2 groups, Group A (study Group) and group B (control group) Group A: Experimental group; combination of core stability exercises and kinesio-taping Group B: control group; only core stability exercises. Data will be analyzed by using SPSS-25. Appropriate statistical test will be used after checking normality of data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

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

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Trunk control with the Trunk Impairment Scale

    The Trunk Impairment Scale (TIS) measures static and dynamic seated trunk control in children with cerebral palsy (CP) who have postural control problems. TIS consists of 17 items in three subscales: static sitting balance, dynamic sitting balance, coordination with a total score range of 0 to 23 points.

    6 weeks

  • Posture and Postural ability scale (PPAS)

    The Posture and Postural Ability Scale is a 7-point ordinal scale for the assessment of postural ability. There are six items for assessment of quality of posture in the frontal plane and another six items in the sagittal plane.

    6 weeks

  • Gait abnormality rating scale (GARS)

    Gait Abnormality Rating Scale (GARS) is a videotape-based analysis of 16 facets of human gait. The Gait Abnormality Rating Scale was designed to observe the gait pattern of older adults with increased fall risk. This scale examines the interaction of the trunk, and upper and lower limb movements during walking. It also includes items that reflect the walking speed and stride length, traditional temporospatial gait parameters, The GARS scale puts more emphasis on assessing overall functional performance. For the elderly, this scale sensitively indicates their deficits during walking and is related to increased fall risk. the intra-rater and inter-rater reliabilities of the total GARS score is 0.708 and 0.875 which is acceptable.

    6 weeks

Study Arms (2)

Experimental group; combination of core stability exercises and kinesio-taping

EXPERIMENTAL

combination of core stability exercises and kinesio-taping were used in experimental group

Other: combination of core stability exercises and kinesio-taping

Control group; only core stability exercises

ACTIVE COMPARATOR

only core stability exercises were given to control group

Other: Core stability exercises

Interventions

the patient in the experimental group will receive the core stability exercises with kinesiology taping on trunk stabilizer muscles. the time of intervention was 30 minutes per day. The exercises such as Abdominal draw-in with a double knee to chest, Trunk twist while sitting on a medicine ball, Lying in a supine position on bed and rotating the trunk from side-to-side, Bridging exercises, the I-shaped elastic KT will apply to the four trunk muscles from their insertion to their origin: Kinesio-taping is used on global muscles such as Rectus abdominis, External obliques, Erector spinae, Quadratus lumborum. Kinesio-taping will 1 inch wide and apply on muscles for 1 to 2 days then remove for 24 hours then again apply a new one. The tension will be 10 to 15% and tape will apply on muscles which will be stretched by maintaining a posture.

Experimental group; combination of core stability exercises and kinesio-taping

After the baseline assessment, the patient in the control group will receive the core stability exercises with kinesio-taping on trunk stabilizer muscles. Time of rehabilitation will be 30 minutes per subject and four days per week. In first few minutes, the subject will be explained her/his task Subject will execute the exercises such as Abdominal draw-in with a double knee to chest 10- 15 times. Trunk twist while sitting on a medicine ball 10- 15 times. Lying in a supine position on bed and rotating the trunk from side-to-side 10- 15 times. Lying in a supine position on a mat and pulling upper and lower limbs upward 10- 15 times. Bridging exercises 10- 15 times, Deep Breathing and Wheelbarrow.

Control group; only core stability exercises

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 7-12 years participants
  • Children with spastic CP.
  • Have ability to keep balance in standing position and take steps without support according to GMFCS level ii.
  • Have ability to follow commands of the examiner

You may not qualify if:

  • allergy to kinesiology taping,
  • Skin diseases such as eczema or psoriasis, congenital curve or due to (neuromuscular, rheumatologic, renal, cardiovascular, pulmonary, or vestibular diseases),
  • patients with metabolic, infectious, traumatic conditions, psychological, psychiatric problems,
  • subjects with any other disorders which lead to changes in spinal curves or any back disorders, such as spondylolysis, spondylolisthesis and lumbosacral transitional anomalies
  • fixed contracture or deformities in the spine or extremities, visual or respiratory disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • Kamel MI, Sayed Elawh Moubarak EE, El-Nassag BA, El-Hakim A-M, Abdulrahman RS. Effects of core stabilization exercise and kinesio taping on pain, Cobb angle and endurance of trunk muscles in children and adolescents with idiopathic scoliosis. Curr Pediatr Res [Internet]. 2022;26(3):1289-1297. Available from: https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02474713/full

    BACKGROUND
  • Lee H, Lim H. Effects of Double-Taped Kinesio Taping on Pain and Functional Performance due to Muscle Fatigue in Young Males: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Mar 31;17(7):2364. doi: 10.3390/ijerph17072364.

    PMID: 32244424BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Alina Amjad, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will be randomized controlled trial used to determine the effect of core stability exercises with and without kinesio-taping in CP children. Subjects with CP meeting the pre-determined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

December 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations