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CTRI Number  CTRI/2025/05/086211 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 29/04/2025
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   Effect Of Nerve Mobilization On Hand Function, Motor Control And Hand Muscle Spasticity In Individuals With Stroke  
Scientific Title of Study   Effect Of Neurodynamics On Hand Function, Motor Control And Hand Muscle Spasticity In Individuals With Hemiparesis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PANKTI RAVI SHAH 
Designation  POST GRADUATE 
Affiliation  Ahmedabad Institute of Medical Science 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Nr S.P. Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060

Ahmadabad
GUJARAT
380060
India 
Phone  07777999085  
Fax    
Email  shahpankti2471@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishali Suthar 
Designation  Lecture, PhD, PG Guide 
Affiliation  Ahmedabad Institute of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Nr S.P. Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060

Ahmadabad
GUJARAT
380060
India 
Phone  9913806872  
Fax    
Email  vaishu82in@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishali Suthar 
Designation  Lecture, PhD, PG Guide 
Affiliation  Ahmedabad Institute of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Nr S.P. Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060

Ahmadabad
GUJARAT
380060
India 
Phone  9913806872  
Fax    
Email  vaishu82in@gmail.com  
 
Source of Monetary or Material Support  
Ahmedabad Institute of Medical Sciences Nr. S.P. Ring Road Ognaj Circle Gota -Kalol Highway Lapkaman Ahmedabad Gujarat India 380060 
 
Primary Sponsor  
Name  Ahmedabad Institute of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Nr S.P. Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishali Suthar  Ahmedabad Institute of Medical Sciences  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Nr S.P. Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad Gujarat India 380060
Ahmadabad
GUJARAT 		 9913806872

vaishu82in@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research And Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Therapy   Stretching of Long Finger Flexors (30 Sec Hold X 3 Times) Strengthening Exercises of All the Upper Extremity Muscles. (10 reps X 2 Sets) Reach Outs with Upper Extremity in Modified Plantigrade Position (20 Reps X 2 Sets) Fine Motor Exercises (2 times X 10 reps) Gripping Exercises (10 Reps X 2 Sets with Gripper)  
Intervention  Neurodynamics  Median Nerve Mobilization 3 sets for (30 repetitions) 2 mins will give followed by 1 min rest total 8-10 mins 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Individuals Diagnosed for Any Type of Stroke for More Than Equal to 3 Months

2. Mini Mental State Examination Is Score More Than Equal to 24

3. Modified Ashworth Scale of Long Finger Flexor & Wrist Flexor Less Than Equal to 2

4. Voluntary Control Grade of Wrist More Than Equal to 3 
 
ExclusionCriteria 
Details  1. Any Orthopedic Condition Affecting Hand Functions Such as Rheumatoid Arthritis, Fractures of Hand etc.

2. Severe Cardiovascular Conditions

3. Presence of Any Perceptual or Psychological Disorders

4. Open Wound on Hand 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Chedoke Arm and Hand Activity Inventory Scale for Hand Function  Baseline and at 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Voluntary control gradation by brunnstrom for Voluntary control  Baseline & at 3 weeks 
Modified Ashworth Scale for Spasticity  Baseline & at 3 weeks 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   N/A 
Date of First Enrollment (India)   01/08/2025 
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="6"
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  
NEED OF THE STUDY:

•   There are studies that indicate around 85% of stroke patients world-wide have hand dysfunction, with 60% still suffering from upper limb disorders, after treatment and discharge.

•   Several studies indicate beneficial effects of Neuro-mobilization in regulating muscle tone, increasing range of motion and improving functional mobility of patients affected by stroke. 

•   Another study also supports that, neural mobilization is efficient in reducing myoelectric activity in the biceps brachii muscle in patients with stroke and may be used by physiotherapists as an efficient method for treating stroke patients.

•   Hand function causes difficulties in performing the most basic activities of daily living (ADL). The rehabilitation of fine motor activity is important for recovering upper limb function.

•   As the hand functions are more neglected in rehab, proximal control develops but distal control is always taken for granted.

•   So, here the strong need arises to assess the hand functions, motor control and hand muscle spasticity by applying Neurodynamics.

 

AIM OF THE STUDY:

•      To study the effect of Neurodynamics on hand function, motor control and hand muscle spasticity in individuals with hemiparesis.


OBJECTIVES OF THE STUDY:

  1. To evaluate effect of conventional therapy on hand function by The Chedoke Arm and Hand Activity Inventory in individuals with hemiparesis.
  2. To evaluate effect of conventional therapy on motor control by Brunnstorm Voluntary Control Gradation in individuals with hemiparesis.
  3. To evaluate effect of conventional therapy on hand muscle spasticity by The Modified Ashworth Scale in individuals with hemiparesis.
  4. To evaluate effect of Neurodynamics on hand function by The Chedoke Arm and Hand Activity Inventory in individuals with hemiparesis who will receive NDS and conventional both treatments.
  5. To evaluate effect of Neurodynamics on motor control by Brunnstorm Voluntary Control Gradation in individuals with hemiparesis who will receive NDS and conventional both treatments.
  6. To evaluate effect of Neurodynamics on hand muscle spasticity by The Modified Ashworth Scale in individuals with hemiparesis who will receive NDS and conventional both treatments.
  7. To compare the effect of Neurodynamics vs. conventional therapy on hand function by The Chedoke Arm and Hand Activity Inventory in individuals with hemiparesis.
  8. To compare the effect of Neurodynamics vs. conventional therapy on motor control by Brunnstorm Voluntary Control Gradation in individuals with hemiparesis.
  9. To compare the effect of Neurodynamics vs. conventional therapy on hand muscle spasticity by The Modified Ashworth Scale in individuals with hemiparesis.


PROCEDURE:

The subject will be divided into two groups

  1. Group A: Neurodynamics
  2. Group B: Conventional therapy with Neurodynamics 
Outcome measures will be recorded before and after intervention

 
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