Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control

Cerebral Palsy Clinical Trial

Official title:

Effect of Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control of Lower Extremity in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06461845
• Other study ID #: REC/PCR&AHS/23/0771
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Imran Amjad, Ph.D
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Permanent neurological disorders such as cerebral palsy lead to problems with motor, sensory, and cognitive functions, which in turn limit one's ability to do certain activities. While the exact causes of cerebral palsy differ from child to child, anoxia-induced brain injury is a major cause of the disorder. The body parts affected, tone, and involuntary motions are used to categorise cerebral palsy. Among all the forms, spastic CP is the most prevalent. In individuals with CP, postural stabilisation and adaptations of the head, trunk, pelvic, and shoulder girdles grow more slowly. The primary problem with CP children is their gross movement pattern, which prevents them from performing single joint movements. Muscle strength increases significantly with WBV exercise training, which also reduces spasticity and enhances CP children's motor function. This study is important because it will determine whether WBV improves trunk control, functional performance, and lower limb selective control.

Data from Rising Sun Institute will be gathered for this randomised clinical trial. 38 patients will be included in the study. The study's inclusion criteria will include CP children with ages between 6 and 12 years old, those who can stand or walk alone (even with unusual gait patterns), GMFCS I and II, and children with diplegic cerebral palsy. Children with cerebral palsy (CP) who have had a lower limb fracture, fixed contracture, or other deformity, as well as those who have had a botulinum toxin injection or selective dorsal rhizotomy within the last six months, will not be eligible. Stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation will be the specific physical therapy treatments administered to group A. In addition, group B will receive WBV in addition to the specific physical therapy treatments (stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation). For two months, the 30-minute sessions will be held three times a week. The Modified Trost Test will test selective lower limb control, the PEDI scale will assess functional performance, and the Trunk Control Measurement Scale will monitor trunk stability before and after sessions. SPSS version 26 will be utilised for data analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: August 30, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• • Childrens who follow verbal command

• Childrens who can stand or walk alone (either with altered pattern)

• Age limit: 6 -12 years

• GMFCS I & II

• Diplegic Cerebral palsy

Exclusion Criteria:

• • Childrens with history of fracture in last 6 months

• Childrens with fixed contracture or other deformity of lower limb

• Childrens having visual or auditory impairments

• Selective dorsal rhizotomy or botulinum toxin injection to lower extremities within past six months

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Whole Body Vibration with conventional therapy
This group will be given WBV training session, by using a WBV platform was conducted to the study group. The wBV program comprises various positions such as the child stands in an erect position, sitting, and in kneeling position on vibrating platform. This platform vibrates horizontally at a frequency ranged from 10 to 25 Hz. The participants had to carry out each position for 2 min in the first month, and then it was increased to 3 min in the second month. The rest period between each position was 1 min in the first month, then it became half a minute in the second month. The duration of the vibration exposure was 10 min.
• conventional therapy
This group will be provided with the conventional physical therapy. To this, stretching activities to keep up muscle elasticity particularly Achilles tendon, hamstring muscles, hip flexors and adductors; strength training to hip flexor, knee extensor, and ankle dorsiflexor;

Locations

Country	Name	City	State
Pakistan	Pakistan Society for Rehabilitation of Disabled	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Ali YMM, Elhadidy EI, Abdou RGE, Darwish SY. EFFECT OF WHOLE BODY VIBRATION ON QUADRICEPS MUSCLE PERFORMANCE IN HEMIPARETIC CHILDREN. 11. Ahmadizadeh Z, Khalili MA, Ghalam MS, Mokhlesin M. Effect of whole body vibration with stretching exercise on active and passive range of motion in lower extremities in children with cerebral palsy: A randomized clinical trial. Iranian Journal of Pediatrics. 2019;29(5)

Annino G, Alashram AR, Alghwiri AA, Romagnoli C, Messina G, Tancredi V, Padua E, Mercuri NB. Effect of segmental muscle vibration on upper extremity functional ability poststroke: A randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14444. doi: 10.1097/MD.0000000000014444. — View Citation

Telford D, Vesey RM, Hofman PL, Gusso S. The Effect of Vibration Therapy on Walking Endurance in Children and Young People With Cerebral Palsy: Do Age and Gross Motor Function Classification System Matter? Arch Rehabil Res Clin Transl. 2020 Jun 20;2(3):100068. doi: 10.1016/j.arrct.2020.100068. eCollection 2020 Sep. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	.Trunk Control Measurement Scale (TCMS) for trunk control	To access trunk control in CP child we choose TCMS, it assesses seated trunk control in three dimensions static sitting balance, dynamic sitting balance and dynamic reaching. The maximum score is 58 points. The items are scored from 0 to 3, with 0 being the inability to perform the task and 3 being the complete performance of the item (20).	Baseline to 8 weeks
Primary	Modified Trost Test for selective control of lower extremity	This test is used for assessment of selective motor control of lower extremity. It is a 3-point scale with assessment of ankle dorsiflexion, knee extension, hip flexion and hip abduction.; 0 point for Only patterned movement observed (total synergy); 1 for Partially isolated movement observed (partial synergy); 2 for Completely isolated movement observed (no synergy)	Baseline to 8 weeks
Primary	PEDI SCALE for functional performance	This scale is use for assessment of functional performance. It is composed of 197 items, subdivided into three domains(22).; Mobility (59 items, involving tub transfers, toilet transfers, indoor and outdoor locomotion, and climbing stairs); Self-care (73 items involving eating, dressing, grooming); Social function (65 items related to communication with comprehension and expression, problem-solving, interactions with peers and adults and safety awareness).; Each item scores (0) for "unable" to perform the activities or (1) for "capable	Baseline to 8 weeks