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Additional Effects of Vagus Nerve Stimulation on Motor Functions of Upper-limb in Stroke

Primary Purpose

Stroke (CVA) or TIA

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Vagus nerve stimulation with task oriented training
Task oriented training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke (CVA) or TIA focused on measuring Impairement, Stroke, Task oriented, Upper limb, Vagus nerve

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Sub-Acute stroke (3 months to 6 months) Between grade 0 and grade 2 on modified Ashworth scale. Patients who will be able to walk without assisted devices and can stand for 2 minutes. Either type Ischemic or Hemorrhagic Age bracket 40-60 Years Exclusion Criteria: Previous surgical intervention on vagus nerve Severe pain in upper extremity MoCA score of less than 10

Sites / Locations

  • Women Institute of Rehabilitation Center and Jinnah international hospital, BBH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vagus nerve stimulation with task oriented training

Task oriented training

Arm Description

Vagus nerve stimulation with task oriented training

Task oriented training alone

Outcomes

Primary Outcome Measures

Fugl Meyer Assessment Scale - Upper Extremity
It is now widely used for clinical assessment of motor function. This is an impairment-based test with items organized by sequential recovery stages. A three-point ordinal scale is used to measure impairments of volitional movement with grades ranging from 0 (item cannot be performed) to 2 (item can be fully performed).Specific descriptions for performance accompany individual test items. Subtests exist for UE function, LE function, balance, sensation, ROM, and pain. The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., UE maximum score is 66, LE score 34; balance score 14). This instrument has good construct validity and high reliability (r 0.99) for determining motor function. Quantifiable outcome data allow this instrument to be accurately used for research purposes (a gold standard) and document recovery over time.
Wolf Motor Function Test (WMFT)
Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. The original version consisted of 21 item; the widely used version of the WMFT consists of 17 items Composed of 3 parts: Time Functional ability Strength Includes 15 function-based tasks and 2 strength based tasks Performance time is referred to as WMFT-TIME. Functional ability is referred to as WMFT-FAS. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The WMFT is an instrument with high interrater reliability, internal consistency, test-retest reliability, and adequate stability
Box and Block Test (BBT)
Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The test-retest reliability for the BBT was reported as excellent (ICC = 0.97; ICC = 0.96) for the right and left hand, respectively. Inter-rater reliability for the BBT, as calculated using the ICC and Spearman rho correlation, was excellent (ICC = 0.99 and r = 0.99).
Nine Hole Peg Test (NHPT)
Nine Hole Peg Test (NHPT) was developed to measure finger dexterity, also known as fine manual dexterity. It can be used with a wide range of populations, including clients with stroke. The NHPT is composed of a square board with 9 pegs. At one end of the board are holes for the pegs to fit in to, and at the other end is a shallow round dish to store the pegs. The NHPT is administered by asking the client to take the pegs from a container, one by one, and placing them into the holes on the board, as quickly as possible. Clients must then remove the pegs from the holes, one by one, and replace them back into the container.On average, healthy male adults complete the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy female adults, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hand, respectively.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
July 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05771805
Brief Title
Additional Effects of Vagus Nerve Stimulation on Motor Functions of Upper-limb in Stroke
Official Title
Additional Effects of Vagus Nerve Stimulation With Task-oriented Training on Motor Functions of Upper-limb in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 25, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke
Detailed Description
Stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours or leading to death with no apparent cause. Nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after stroke. The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke. The idea of stimulating the vagus nerve to modify central brain activity has been pursued. Vagus nerve stimulation (VNS) paired with rehabilitative training enhances recovery of function in models of stroke and is currently under investigation for use in chronic stroke patients. Compared to traditional stimulation, noninvasive VNS seems to be safer and more tolerable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke (CVA) or TIA
Keywords
Impairement, Stroke, Task oriented, Upper limb, Vagus nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vagus nerve stimulation with task oriented training
Arm Type
Experimental
Arm Description
Vagus nerve stimulation with task oriented training
Arm Title
Task oriented training
Arm Type
Active Comparator
Arm Description
Task oriented training alone
Intervention Type
Other
Intervention Name(s)
Vagus nerve stimulation with task oriented training
Intervention Description
VNS Group will receive non-invasive vagus nerve stimulation at left auricle of ear for 30 mins during the task-oriented training. Subjects will receive protocol 3 days per week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Task oriented training
Intervention Description
Task oriented group will receive task oriented training and placebo effect with vagus nerve stimulator.
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment Scale - Upper Extremity
Description
It is now widely used for clinical assessment of motor function. This is an impairment-based test with items organized by sequential recovery stages. A three-point ordinal scale is used to measure impairments of volitional movement with grades ranging from 0 (item cannot be performed) to 2 (item can be fully performed).Specific descriptions for performance accompany individual test items. Subtests exist for UE function, LE function, balance, sensation, ROM, and pain. The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., UE maximum score is 66, LE score 34; balance score 14). This instrument has good construct validity and high reliability (r 0.99) for determining motor function. Quantifiable outcome data allow this instrument to be accurately used for research purposes (a gold standard) and document recovery over time.
Time Frame
12 weeks
Title
Wolf Motor Function Test (WMFT)
Description
Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. The original version consisted of 21 item; the widely used version of the WMFT consists of 17 items Composed of 3 parts: Time Functional ability Strength Includes 15 function-based tasks and 2 strength based tasks Performance time is referred to as WMFT-TIME. Functional ability is referred to as WMFT-FAS. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The WMFT is an instrument with high interrater reliability, internal consistency, test-retest reliability, and adequate stability
Time Frame
12 weeks
Title
Box and Block Test (BBT)
Description
Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The test-retest reliability for the BBT was reported as excellent (ICC = 0.97; ICC = 0.96) for the right and left hand, respectively. Inter-rater reliability for the BBT, as calculated using the ICC and Spearman rho correlation, was excellent (ICC = 0.99 and r = 0.99).
Time Frame
12 weeks
Title
Nine Hole Peg Test (NHPT)
Description
Nine Hole Peg Test (NHPT) was developed to measure finger dexterity, also known as fine manual dexterity. It can be used with a wide range of populations, including clients with stroke. The NHPT is composed of a square board with 9 pegs. At one end of the board are holes for the pegs to fit in to, and at the other end is a shallow round dish to store the pegs. The NHPT is administered by asking the client to take the pegs from a container, one by one, and placing them into the holes on the board, as quickly as possible. Clients must then remove the pegs from the holes, one by one, and replace them back into the container.On average, healthy male adults complete the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy female adults, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hand, respectively.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sub-Acute stroke (3 months to 6 months) Between grade 0 and grade 2 on modified Ashworth scale. Patients who will be able to walk without assisted devices and can stand for 2 minutes. Either type Ischemic or Hemorrhagic Age bracket 40-60 Years Exclusion Criteria: Previous surgical intervention on vagus nerve Severe pain in upper extremity MoCA score of less than 10
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arshad Nawaz Malik, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women Institute of Rehabilitation Center and Jinnah international hospital, BBH
City
Abbottabad
State/Province
KPK
ZIP/Postal Code
22010
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Additional Effects of Vagus Nerve Stimulation on Motor Functions of Upper-limb in Stroke

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