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CTRI Number  CTRI/2024/06/068657 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 19/12/2024
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   Improving Upper limb functional Abilities and brain activity After Stroke: Nerve Mobilization Effects 
Scientific Title of Study   Effect of Upper limb Peripheral Nerve Mobilization on Motor Abilities, Nerve conduction, and Cortical activity in subjects with middle cerebral artery (MCA) Stroke 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surya Vishnuram 
Designation  PhD Scholar 
Affiliation  Saveetha College of Physiotherapy 
Address  C5A Hall, Department of Community, Geriatrics and palliative care physiotherapy, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Thandalam

Chennai
TAMIL NADU
602105
India 
Phone  8508577724  
Fax    
Email  suryavishnuram@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kumaresan Abathsagayam 
Designation  Professor and PhD Guide 
Affiliation  Saveetha College of Physiotherapy 
Address  C5A Hall, Department of Community, Geriatrics and palliative care physiotherapy, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Thandalam

Chennai
TAMIL NADU
602105
India 
Phone    
Fax    
Email  kresh49@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Surya Vishnuram 
Designation  PhD Scholar 
Affiliation  Saveetha College of Physiotherapy 
Address  C5A Hall, Department of Community, Geriatrics and palliative care physiotherapy, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Thandalam

Chennai
TAMIL NADU
602105
India 
Phone  8508577724  
Fax    
Email  suryavishnuram@gmail.com  
 
Source of Monetary or Material Support  
Self funded study will be conducted in Saveetha Medical College and Hospitals (SMCH), Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai, Tamilnadu, India, 602105 
 
Primary Sponsor  
Name  Surya Vishnuram 
Address  Self funded study will be conducted in Saveetha Medical College and Hospitals (SMCH), Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai, Tamilnadu, India, 602105 
Type of Sponsor  Other [Self funded] 
 
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 Surya Vishnuram  Saveetha Medical College and Hospital  C5A Hall, Department of Community, Geriatrics and palliative care physiotherapy, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Thandalam
Chennai
TAMIL NADU 
8508577724

suryavishnuram@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethical Committee (SMCH-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Peripheral Nerve Mobilization  Experimental group will be receiving upper limb Peripheral Neural Mobilization (PNM) techniques along with standard stroke rehabilitation protocol. Upper limb Peripheral Neural Mobilization (PNM) techniques involve the application of gentle, controlled movements to specific peripheral nerves to improve neural health and function. The appropriate treatment duration for each session will be based on the patient’s tolerance, typically starting with shorter durations and gradually increasing as the patient progresses. 45 minutes of standard stroke rehabilitation protocol and 15 minutes of upper limb peripheral nerve mobilization will be implemented for Experimental group. Median Nerve Glide: Patient lies supine with shoulder at 90° abduction and external rotation, forearm in supination, and wrist neutral with fingers supinated. Therapist applies coordinated elbow and cervical movements. Tensioning involves opposite movements. Radial Nerve Glide: Patient stands relaxed. Therapist guides through shoulder depression, wrist flexion, internal rotation, lateral cervical flexion, and wrist flexion with shoulder extension, ensuring gentle tension without pain. Ulnar Nerve Glide: Similar to radial nerve glide, patient stands relaxed. Therapist guides through shoulder depression, wrist flexion, internal rotation, lateral cervical flexion, and wrist flexion with shoulder extension, ensuring gentle tension without pain. 
Comparator Agent  standard stroke rehabilitation protocol  45 minutes of standard stroke rehabilitation protocol and 15 minutes of upper limb muscular stretches will be implemented for Control group. Participants in the control group will receive standard stroke rehabilitation protocol, which encompasses a variety of interventions aimed at promoting recovery. This includes employing diverse sensory stimulation techniques to facilitate movement and enhance motor control, along with specific exercises targeting the restoration of motor function, spasticity management, and hemiplegia. Limb physiotherapy sessions will focus on improving range of motion and strengthening exercises. Additionally, participants will undergo tone management, balance retraining, and fall prevention strategies, alongside gait re-education and functional mobility training. Furthermore, 15 minutes of upper limb muscular stretches will be incorporated into each session to promote flexibility and mobility. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1) Middle cerebral artery (MCA) Stroke subjects aged 40-75 years,
2) Less than 6 months of stroke onset (acute and sub-acute),
3) Subjects with mild to moderate functional impairments assessed using national institute of health stroke scale (NIHSS) scale,
4) Voluntary motor control (VMC) grading more than 3,
5) Modified Ashworth Scale (MAS) less than 1+,
6) Both male and female will be included 
 
ExclusionCriteria 
Details  1. Severe muscle stiffness with Voluntary motor control (VMC) less than 3
2. Stroke subjects with other artery involvement (Anterior Cerebral Artery, Posterior Cerebral Artery or other)
3. Participants with recurrent stroke and other neurological disorders.
4. Participants with other musculoskeletal disorders.
5. Participants with radiculopathy.
6. Red flag signs as tumour, cancer, severe osteoporosis.
7. Participation in other trials 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional Magnetic Resonance Imaging (FMRI)  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
, Nerve Conduction study, Wolf Motor Function Test  8 weeks 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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/ Phase 3 
Date of First Enrollment (India)   01/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
Vishnuram, S., A, K., Suganthirababu, P., Ramalingam, V., Srinivasan, V., & Alagesan, J. (2024). Effect of Peripheral Nerve Mobilization and VR-Based Gait Training on Gait Parameters Among Patients With Chronic ACA Stroke – A Pilot Study . Physical & Occupational Therapy In Geriatrics, 42(4), 470–480. https://doi.org/10.1080/02703181.2024.2332253 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction: -Stroke is a debilitating neurological condition that occurs when the blood supply to the brain is disrupted, leading to a sudden loss of brain function. Stroke can give rise to various complications that further impact the individual’s functional abilities and overall well-being. These complications include muscle contractures, spasticity, joint stiffness, pain, reduced mobility, and a heightened risk of falls and injuries. These factors contribute to long-term disability and reduced quality of life for stroke survivors. Current interventions for stroke rehabilitation typically focus on motor impairments and functional recovery through various rehabilitation approaches. These interventions aim to improve muscle strength, coordination, and relearn functional tasks. While these conventional approaches have shown efficacy, there is a growing recognition that neural factors may play a crucial role in functional recovery after stroke. Peripheral nerve mobilization (PNM) techniques aim to reduce neural tension, enhance nerve gliding, and promote neural tissue mobility. These techniques have been used in various musculoskeletal and neurological conditions, demonstrating promising effects on nerve conduction, functional improvement, and cortical activity.

 

Need of the study: -This study will contribute to the understanding of the potential benefits of peripheral nerve mobilization as a key rehabilitation approach in stroke care, addressing the neural aspects of recovery that may have been overlooked by conventional therapies. The findings will provide valuable insights for the development of more comprehensive and tailored rehabilitation strategies for stroke survivors, ultimately improving their overall functional outcomes and quality of life.

 

Objectives: -

a) To assess the effect of upper limb peripheral nerve mobilization on motor abilities in middle cerebral artery stroke subjects.

b) To examine the effect of upper limb peripheral nerve mobilization on cortical activity in middle cerebral artery stroke subjects.

C) To assess the effect of upper limb peripheral nerve mobilization on median, radial, and ulnar nerve conduction in middle cerebral artery stroke subjects.

 

 

 

 

Methodology: - 66 participants will be recruited with middle cerebral artery (MCA) Stroke based on selection criteria. Informed consent and information sheet will be explained and obtained from all participants with their voluntary consent. Included participants will be undergoing pretest such as Fugl Meyer Assessment – upper limb (FMA- UL) for functional performance, Functional Magnetic resonance Imaging (FMRI) for Cortical Activity, and Nerve conduction study for Radial, Median, and Ulnar nerve conduction velocity.

After completion of the pre-test, Participants will be allocated in to two groups by concealed envelope method as Experimental group (n=33) and Control group (n=33). Experimental group will be receiving Peripheral Neural Mobilization (PNM) techniques along with conventional exercises and control group will be receiving conventional exercises alone. Both the groups will be treated for 1 hour session per day, 4 days a week for a period of 8 weeks.

 

Statistical analysis:-Sample size (66) is estimated assuming 4% population proportion with 5% significance level and 95% confidence interval with 10% drop-out rate. For both experimental and control group samples will be allocated through concealed envelope as 33 in each group. Statistical analysis will be performed using Mann-Whitney U tests for between-group comparisons and Wilcoxon test for within-group comparisons.

Expected outcomes: -

The primary expected outcomes of the study include significant improvements in cortical activity and connectivity patterns of Functional MRI indicating the effectiveness of upper limb peripheral nerve mobilization (PNM). Additionally, enhanced nerve conduction in the Radial, Median, and Ulnar nerves post-intervention is anticipated, reflecting improved nerve functionality. Also improved motor abilities, measured through the wolf motor function test (WMFT) is expected. 
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