| CTRI Number |
CTRI/2019/09/021442 [Registered on: 30/09/2019] Trial Registered Prospectively |
| Last Modified On: |
23/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Therapy for Sensory Deficit in Patients with half-side body paralysis |
|
Scientific Title of Study
|
Neuralplasticity-based Sensory-Rehabilitation Protocol
in Post-Stroke Hemiparesis
|
| Trial Acronym |
NEPSER |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamal Narayan Arya |
| Designation |
Lecturer Occupational Therapy |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities |
| Address |
Room No. 24 Department of Occupational Therapy, Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities, 4 Vishnu Digamber Marg
New Delhi
DELHI
110002
India |
| Phone |
011-23232403 |
| Fax |
011-23239690 |
| Email |
kamalnarya@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Narayan Arya |
| Designation |
Lecturer Occupational Therapy |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities |
| Address |
Room No. 24 Department of Occupational Therapy, Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities, 4 Vishnu Digamber Marg
New Delhi
DELHI
110002
India |
| Phone |
011-23232403 |
| Fax |
011-23239690 |
| Email |
kamalnarya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Narayan Arya |
| Designation |
Lecturer Occupational Therapy |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities |
| Address |
Room No. 24 Department of Occupational Therapy, Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities, 4 Vishnu Digamber Marg
New Delhi
DELHI
110002
India |
| Phone |
011-23232403 |
| Fax |
011-23239690 |
| Email |
kamalnarya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi. |
| Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan,
Ansari Nagar, New Delhi - 110022.
|
| Type of Sponsor |
Government funding agency |
|
|
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 Kamal Narayan Arya |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities |
Department of Occupational therapy, 4 Vishnu Digamber Marg New Delhi 110002
New Delhi
DELHI |
9899897408
kamalnarya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Pt. Deendayal Upadhyaya National Institute for Persons withPhysical Disabilities |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I630||Cerebral infarction due to thrombosis of precerebral arteries, (2) ICD-10 Condition: I611||Nontraumatic intracerebral hemorrhage in hemisphere, cortical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional motor rehabilitation |
Motor therapy based on conventional neurophysiological approaches comprises activities and functional tasks for the impaired upper limb. |
| Intervention |
NEuroplasticity-Principles-based SEnsory-Rehabilitation (NEPSER) |
Protocol is based on the key principles of neuroplasticity established in relation to the rehabilitation of stroke subjects. The application of the principles, therapy guidelines, level of therapy (mirror therapy, active, and passive sensory stimulation, functional usage, will be selected as per the type of sensory deficits (impaired touch, discrimination, stereognosis, proprioception) and motor recovery stage of the upper limb. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Hemiparesis (right or left) (as assessed by Fugl-Meyer assessment62 upper extremity subsection: 0 to 66)
First episode of unilateral stroke (as defined by WHO)
Ischemic or hemorrhagic stroke
1 to 12 months after the stroke onset
Impaired or more sensory deficit of any of the sensory modalities (< 7/8)13 as discerned by Nottingham Sensory Assessment (Erasmus MC modification of the revised version)63
Normal visual abilities (with or without glasses)
|
|
| ExclusionCriteria |
| Details |
Receptive communication or other language disorder (which could interfere with the assessment and treatment process)
Contractures and deformities of hand / finger
Use of hand splinting or orthosis
Complex regional pain syndrome
Severe cognitive or perceptual deficit
Concomitant medical illness
Cardiovascular instability: resting systolic blood pressure >200mmHg and resting diastolic blood pressure >100 mmHg
Pregnancy
Renal infection or failure
Severe depression (Beck depression inventory > 30)
Diabetic or any other neuropathy
Skin disorder
Peripheral nerve injury of either of the upper limbs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl-Meyer Assessment, Nottingham Sensory Assessment (Erasmus MC modification of the revised version) |
Baseline, 8-week, 12-week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Semmes Weinstein Monofilament, Two-Point Discrimination,3. Modified Rankin scale |
Baseline, 8-week, 12-week |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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 3 |
|
Date of First Enrollment (India)
|
01/11/2019 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Planned to publish protocol and final outcome in a journal of reputee |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary objectives 1.
To
determine the effectiveness of a neuralplasticity principles based sensory
rehabilitation protocol on motor recovery of the post-stroke hemiparetic
subjects
2.
To
determine the effectiveness of the protocol on sensory recovery of the subjects In spite of well-established fact that the recovery of
motor function following stroke is worsened by somatosensory impairments, very
negligible intervention techniques have been developed and tested for the
recovery. Further,
there is insufficient evidence for their effectiveness in improving the sensory
deficit and associated motor recovery, functional performance, and
participation.The major reason for the failure of these sensory interventions
was lack of the neuroplasticity principles in formulation of the program. Thus, a structured and scientifically based program
for enhancing the sensory recovery and associated motor recovery has not been
investigated yet. Sensory deficit is an important, though scarcely
explored area in Stroke-Rehabilitation. The sensory impairment undoubtedly
affects the motor paresis which is still a challenge among stroke subjects.
This study will lead to development of a novel rehabilitation protocol for the
management of sensory-motor deficits in stroke. The protocol will not only enhance the
sensory recovery but also the motor and functional recovery. The improved
sensation and motor activity will allow the subjects to utilize the paretic
upper limb in daily performances. This will reduce the impact of stroke
disability and enhance the quality of life. The study, once successful, can be applied for stroke
rehabilitation in various institutions, centers, and hospitals across the country
imroving the health care for the post-stroke survivors.
|