| 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
|
|
|
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
|
|
|
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. |
|
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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. |