Effects of Transcutaneous Electrical Nerve Stimulation on Spasticity in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Age 6-12
- Both Male and Female
- Spastic Cerebral Palsy
Exclusion Criteria:
- Patients with History of uncontrolled seizures
- Patients undergoing previous tendon lengthening surgery
- History of Botox Injection
Sites / Locations
- DHQ HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Group D
Arm Description
participants in this group will be given with TENS to spastic Hams, Adductor and TA along with stretchings and ROM as baseline treatment
participants in this group will be given with TENS to opposite of spastic muscles, i.e. quards, abductor and dorsiflexors along with stretchings and ROM as baseline treatment
participants in this group will be given with TENS to both spastic muscles and opposite of spastic muscle along with stretchings and ROM as baseline treatment
participants in this group will be given with stretchings and ROM as baseline treatment
Outcomes
Primary Outcome Measures
Change in Modified Ashworth Scale
The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.
0 No increase in tone
1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension.
1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed 3 considerable increase in tone, passive movement difficult 4 limb rigid in flexion or extension
Change in Modified Tardieu Scale
The Modified Tardieu Scale (MTS) is an often-recommended spasticity assessment.The MTS classifies the response of a relaxed muscle to a fast, passive stretch (V3). The assessment protocol involves a clinician moving the joint "as fast as possible" through its full range of motion (ROM) without specifying or measuring the speed of completion. The MTS is applied according to this standardized protocol regardless of the functional status or goals of the patient.
Secondary Outcome Measures
Full Information
NCT ID
NCT05463159
First Posted
June 20, 2022
Last Updated
July 14, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05463159
Brief Title
Effects of Transcutaneous Electrical Nerve Stimulation on Spasticity in Children With Cerebral Palsy
Official Title
Effects of Transcutaneous Electrical Nerve Stimulation on Spasticity in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cerebral Palsy (CP) is a group of mental disorder that disrupts the person's ability of moving, maintaining their balance and posture. Cerebral palsy is a motor disorganization in Childhood. Cerebral palsy can occur before birth, during birth, within a month after birth, or during 1st year of life when brain is under development. Symptoms vary from person to person in case of severe CP child must needs the equipment used to enhance their mobility and to train muscles. Transcutaneous electrical nerve stimulation (TENS) is method of relieving pain by using mild electric current. Purpose of this study will be to determine effects of TENS on spasticity and gross motor function in children with cerebral palsy. TENS is a small machine operated with battery containing attached sticky pads known as electrodes placed on stiffed and painful area of muscles. Classified by Ashworth Scale and Modified Tardieu Scale. Subjects will be randomly divided into four groups 1) Group A= TENS on spastic muscle/agonist, 2) Group B= TENS on antagonist, 3) GroupC= TENS on both agonist and antagonist muscle, Group D= conventional physiotherapy total treatment period is about 3 to 6 weeks. This study will help to discuss how much extent TENS will effect spasticity in children with cerebral palsy. Data will be analyzed through SPSS 22
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
participants in this group will be given with TENS to spastic Hams, Adductor and TA along with stretchings and ROM as baseline treatment
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
participants in this group will be given with TENS to opposite of spastic muscles, i.e. quards, abductor and dorsiflexors along with stretchings and ROM as baseline treatment
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
participants in this group will be given with TENS to both spastic muscles and opposite of spastic muscle along with stretchings and ROM as baseline treatment
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
participants in this group will be given with stretchings and ROM as baseline treatment
Intervention Type
Other
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
All children received 30 min of conventional TENS (continuous stimulation with all parameters constant) with a frequency of 100 Hz and a pulse width of 200 µs.
Primary Outcome Measure Information:
Title
Change in Modified Ashworth Scale
Description
The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.
0 No increase in tone
1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension.
1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed 3 considerable increase in tone, passive movement difficult 4 limb rigid in flexion or extension
Time Frame
Baseline and 4th week
Title
Change in Modified Tardieu Scale
Description
The Modified Tardieu Scale (MTS) is an often-recommended spasticity assessment.The MTS classifies the response of a relaxed muscle to a fast, passive stretch (V3). The assessment protocol involves a clinician moving the joint "as fast as possible" through its full range of motion (ROM) without specifying or measuring the speed of completion. The MTS is applied according to this standardized protocol regardless of the functional status or goals of the patient.
Time Frame
Baseline and 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 6-12
Both Male and Female
Spastic Cerebral Palsy
Exclusion Criteria:
Patients with History of uncontrolled seizures
Patients undergoing previous tendon lengthening surgery
History of Botox Injection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Ph.D
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Fareeha Kausar, PP-DPT
Phone
03216758180
Email
fareeha.kausar@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ Hospital
City
Vehari
State/Province
Punjab
ZIP/Postal Code
61100
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, PP-DPT
Phone
03216758180
Email
fareeha.kausar@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Aden Riaz, MSPT (Pead)
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30913943
Citation
Alhusaini AA, Fallatah S, Melam GR, Buragadda S. Efficacy of transcutaneous electrical nerve stimulation combined with therapeutic exercise on hand function in children with hemiplegic cerebral palsy. Somatosens Mot Res. 2019 Mar;36(1):49-55. doi: 10.1080/08990220.2019.1584555. Epub 2019 Mar 26.
Results Reference
background
PubMed Identifier
28063935
Citation
Solopova IA, Sukhotina IA, Zhvansky DS, Ikoeva GA, Vissarionov SV, Baindurashvili AG, Edgerton VR, Gerasimenko YP, Moshonkina TR. Effects of spinal cord stimulation on motor functions in children with cerebral palsy. Neurosci Lett. 2017 Feb 3;639:192-198. doi: 10.1016/j.neulet.2017.01.003. Epub 2017 Jan 4.
Results Reference
background
PubMed Identifier
30061001
Citation
Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep-Oct;52(5):581-586. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 Jul 20.
Results Reference
background
PubMed Identifier
21876294
Citation
Alabdulwahab SS. Electrical stimulation improves gait in children with spastic diplegic cerebral palsy. NeuroRehabilitation. 2011;29(1):37-43. doi: 10.3233/NRE-2011-0675.
Results Reference
background
PubMed Identifier
20203376
Citation
Alabdulwahab SS, Al-Gabbani M. Transcutaneous electrical nerve stimulation of hip adductors improves gait parameters of children with spastic diplegic cerebral palsy. NeuroRehabilitation. 2010;26(2):115-22. doi: 10.3233/NRE-2010-0542.
Results Reference
background
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Effects of Transcutaneous Electrical Nerve Stimulation on Spasticity in Children With Cerebral Palsy
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