| CTRI Number |
CTRI/2024/05/068082 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Neurodynamic technique on spasticity in spastic diplegic patients |
|
Scientific Title of Study
|
Effect of neurodynamic technique on spasticity in spastic diplegic cerebral palsy patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VARNIKA PAL |
| Designation |
Post Graduation Student |
| Affiliation |
Shri guru ram rai university, School of paramedical sciences and allied health sciences |
| Address |
Shri Mahent Indiresh Hospital Department of Physiotherapy North Block, Basement
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7088970710 |
| Fax |
|
| Email |
varnikastud@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surbhi Thapliyal PT |
| Designation |
Assistant Professor |
| Affiliation |
Shri guru ram rai university, School of paramedical sciences and allied health sciences |
| Address |
Shri Mahent Indiresh Hospital Department of Physiotherapy North Block, Basement
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8979082369 |
| Fax |
|
| Email |
surbhithapliyal.pt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surbhi Thapliyal PT |
| Designation |
Assistant Professor |
| Affiliation |
Shri guru ram rai university, School of paramedical sciences and allied health sciences |
| Address |
Shri Mahent Indiresh Hospital Department of Physiotherapy North Block, Basement
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8979082369 |
| Fax |
|
| Email |
surbhithapliyal.pt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Rai RAI University, School Of Paramedical And Allied Health Sciences, Pathribagh, Dehradun, Uttarakhand , 248001 |
|
|
Primary Sponsor
|
| Name |
Varnika Pal |
| Address |
Shri Guru Rai RAI University, School Of Paramedical And Allied Health Sciences, Pathribagh, Dehradun, Uttarakhand , 248001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr varnika Pal PT |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
Shri Mahant Indiresh Hospital Department of Physiotherapy North Block, Basement
Dehradun
UTTARANCHAL |
7088970710
varnikastud@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL PHYSIOTHERAPY METHOD |
Each subject will receive Balancing exercises, Weight bearing exercises, Positional exercises, Walking exercises, Coordination exercises, Core stability exercises for 4days/6 weeks.
Duration will be 30 min |
| Intervention |
Neurodynamic Technique for reducing spasticity in lower limbs in spastic diplegic cerebral palsy patients |
Each subject will receive the treatment for 4 days/6 weeks.
Duration will be 15-20 min.
Neurodynamic treatment will be given in lower limbs with 5-10 repitions with tensioner and sliding technique. neural stretch will be given for sural, tibial and fibular nerve and adding the straight leg raise dynamic movement after the stretch till the pain free range of motion |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of spastic diplegic cerebral palsy, aged 6 to up to 18 years.
Gross motor function classification system Levels- 1-3.
Both genders |
|
| ExclusionCriteria |
| Details |
Any types of orthopedic surgery on lower limb in last 12 months.
Imposed medical restriction for weight bearing.
Children who cannot walk independently or at least with a walking aid.
If they had an arthrodosis of the ankle joint, a flexion contracture of more than 5-degree in the knee joint or less than 80-degree hip flexion with the knee flexed.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Ashworth Scale for assessing spasticity |
1st day, 21st day, 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gross Motor Function Classification System for assessing motor function |
1st day, 21st day, 42nd day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neurodynamic technique focus on how the nervous system influences musculoskeletal function and movement. It involves assessing and treating nerve mobility and sensitivity to improve pain, function and overall movement pattern. This technique refers to therapeutic method (manual technique or exercises) which facilitate the movement between the nervous system and its interfacing tissues (for example- mobilizing the nervous system itself, including the internal neural connective tissue layer, or the structures that surround the nervous system) or reduce the mechanical loading on the nervous system. Neural mobilization generally consists of technique termed neural glides or neural flossing |