Comparative study of Neuro-Developmental Treatment and Electrical stimulation in cerebral palsy children.

Not yet recruiting

Conditions: Cerebral palsy, unspecified,

Registration Number: CTRI/2022/02/039899

Lead Sponsor: NA

Brief Summary: A total of 30 subjects will be recruited in the study. An informed consent form will be given to all participants or parents. The motive of the study will be explained to the participants and parents. Participants will be divided into 2 groups: experimental and control.

Experimental group will be of cerebral palsy patients receiving Neuro-Developmental Treatment (Bobath Concept) combined with Electrical stimulation, Control group will include cerebral palsy patients receiving Neuro-Developmental Treatment (Bobath Concept) alone. In each group, an equal division of participants will be taken, with a ratio of 15:15.

A registration form will be filled for the subjects defining their demographics, CP clinical type, limb involvement, medical histories, walking aid use, surgical operation history, and NDT history. Subjects will be assessed before and after the intervention through face-to-face interaction. Physiotherapist will assess the patient using the various scales like GMFCS and GMFM-88 for Gross motor function, Paediatric Balance Scale and Modified timed Up and Go Test (MTUGT) for balance.

Experimental groups will receive training 1 hour. For 4 days for 6 weeks. Experimental Group will receive the NDT+ES. NDT includes Vestibular and proprioceptive training on balance board, Vestibular and proprioceptive training on exercise balls in different sizes. Dynamic balance training in sitting, kneeling, and standing position (eyes open and closed). Balance exercises in front of the mirror. Standing on one foot for improving the proprioceptive input (eyes open and closed). Balance training on the trampoline. Sensory stimulation for foot soles with various materials. Weight bearing exercises in sitting, crawling, kneeling, and standing position. Functional reaching and ball throwing-keeping exercises in various positions. Multi-task trainings. Walking trainings in different types. Climbing up & stepping down the stairs (supported-unsupported, symmetric, reciprocal etc.)

Electrical stimulation will be given over the paravertebral muscles when the subject is in sitting position. Pulse duration will be established as 14.65 microseconds with frequency of 60 Hz, and current strength will determine to form a tetanic contraction. Application duration will 10 minutes and the application frequency was 4 weeks/day for 6 weeks.

Electrical stimulation will be given inside lying position for gluteus maximus and in sitting position for quadriceps. During the application of neuromuscular electrical stimulation, child was positioned with the knee flexed (70-80 degree) and the hamstring will not in the lengthened position to reduce the amount of stimulation required to attain a forceful contraction and therefore improve comfort. The intervention period was of 6 weeks duration, electrical stimulation for 10 minutes each muscle, 4 days/week. Parameters used: Waveform- balance, symmetrical, biphasic; Pulse duration - 300 ms; Frequency 50 pulse/sec; Stimulation time: Rest time on:off 15:5, Ramp up â€“ 1 sec, Ramp down- sec; Intensity - maximum tolerable intensity by the child.

Control Group will receive only the Neurodevelopmental Treatment Protocol For 35 minutes for 4 day/week for 6 weeks.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Acceptance of childâ€™s participation in the study (by parents and/or their legal representatives) 2.CP diagnosed 3.Ages between 5-15 years 4.Cooperative 5.Walking independently or with a walking aid (Gross Motor Function Classification System (GMFCS) Level I, II or III).

Exclusion Criteria

1.Different diagnosis from CP 2.Children who cannot walk independently or at least with a walking aid (GMFCS Level IV or V) 3.To be not attended the assessments or the therapy sessions regularly.
But all the participants were attended every session properly.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postural control and Balance	Week-0, Week-6

Secondary Outcome Measures

Name	Time	Method
Motor Performance	Week-0, Week-6

Trial Locations

Locations (1): Reborn Physiotherapy & Neuro Rehab Centre.
🇮🇳
Ghaziabad, UTTAR PRADESH, India
Reborn Physiotherapy & Neuro Rehab Centre.
🇮🇳Ghaziabad, UTTAR PRADESH, India
Dr Himandri Kapil
Principal investigator
9560809242
himandri.k@gmail.com