Spastic Cerebral PalsyNCT06198127
Effect of Core Stability Exercises With and Without Kinesio-Taping in CP Children
A study testing combination of core stability exercises and kinesio-taping and Core stability exercises in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- combination of core stability exercises and kinesio-taping and Core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Core Stability Exercises With and Without Kinesio-taping on Trunk Control, Gait and Posture in Children With Cerebral Palsy
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.
Read the detailed 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 .
- Conditions
- Spastic Cerebral Palsy
- Being tested
- combination of core stability exercises and kinesio-taping, Core stability exercises
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of core stability exercises and kinesio-tapingOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group; combination of core stability exercises and kinesio-taping | Experimental | combination of core stability exercises and kinesio-taping were used in experimental group Receives: 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 Receives: Other: Core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alina Amjad, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198127
- Sponsor's protocol ID
- REC/RCR&AHS/23/0748
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32244424
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stability Exercises With and Without Kinesio-taping on Trunk Control, Gait and Posture in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06198127
- Acronym / sponsor ID
- REC/RCR&AHS/23/0748
- Conditions
- Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group; combination of core stability exercises and kinesio-taping | Experimental | Other: combination of core stability exercises and kinesio-tapingcombination of core stability exercises and kinesio-taping were used in experimental group |
| Control group; only core stability exercises | Active comparator | Other: Core stability exercisesonly core stability exercises were given to control group |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination of core stability exercises and kinesio-tapingthe 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. | Other | Experimental group; combination of core stability exercises and kinesio-taping |
| Core stability exercisesAfter 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. | Other | Control group; only core stability exercises |
Primary outcome
Trunk control with the Trunk Impairment Scale
Time frame: 6 weeks
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.
Posture and Postural ability scale (PPAS)
Time frame: 6 weeks
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.
Gait abnormality rating scale (GARS)
Time frame: 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- BackgroundKamel 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: PubMed 32244424Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Amjad, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of core stability exercises and kinesio-taping and Core stability exercises in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk control with the Trunk Impairment Scale (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198127, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.