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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06198127
Other study ID # REC/RCR&AHS/23/0748
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date February 5, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Experimental Group: After the baseline assessment, the patient in the experimental 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.(4) Kinesio-taping: The area to be taped will be cleaned with an alcohol swab, and the I-shaped elastic Kinesio-taping 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. For the rectus abdominis (RA) muscle, the kinesio-taping will be applied from the xiphoid process and the fifth to seventh costal cartilages to near the pubic symphysis in the hooking position. For the external oblique (EO) muscle, the kinesio-taping will be applied from the inguinal region to the T12 spinous process in the side-lying position, and for the internal oblique (IO) muscle, the kinesio-taping will be applied from the xiphoid process to the anterior half of the crest of the ilium in the same position. For the erector spinae muscle, the kinesio-taping will be applied from the ipsilateral transverse process of T12 to the posterior sacrum iliac crest. 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 . Control Group : 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 .


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
combination of core stability exercises and kinesio-taping
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.
Core stability exercises
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.

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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