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Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients

Primary Purpose

Stroke, Subacute

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Treatment
Focal Muscle Vibration (120Hz)
Focal Muscle Vibration (60Hz)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Subacute

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hemiplegic affected side spastic <3 on the Ashworth scale.
  • History of stroke should be > 6 weeks and <12 weeks.

Exclusion Criteria:

  • Individuals with the other neurological deficit
  • Diabetic ulcer, infection or amputation of limb
  • Serious cardiovascular disease or unstable angina
  • Serious orthopedic problem
  • Chronic medical problems

Sites / Locations

  • Railway General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional Treatment

Focal Muscle Vibration (120Hz)

Focal Muscle Vibration (60Hz)

Arm Description

Conventional Treatment includes exercises limbs

Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 120 Hz. Conventional Treatment

Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 60 Hz. Conventional Treatment

Outcomes

Primary Outcome Measures

Fugl Meyer Scale (FMS)
Changes from the Baseline this scale was measured Fugl Meyer Assessment is the utmost extensively used and approved clinical scale for assessment of sensorimotor loss in post stroke patients.This scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities) Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints) Balance (contains 7 tests, 3 seated and 4 standing) Joint range of motion (8 joints) Joint pain 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226. MAS detecting the changes in muscle tone in patients with stroke.. It's a 6 point scale. 0=no muscle tone, 4= affected parts rigid flexion or extension.Its reliability is 0.567.
Motor Assessment Scale (MAS)
Changes from the Baseline this scale was measured . The Motor Assessment Scale (MAS) is used to assess everyday motor function in patients with stroke. 8 items assess 8 areas of motor function Patients perform each task 3 times, only the best performance is recorded Items (with the exception of the general tonus item*) are assessed using a 7-point scale (0 to 6) A score of 6 indicates optimal motor behavior Item scores (with the exception of the general tonus item) are summed to provide an overall score (out of 48 points) Completing a higher-level item suggests successful performance on lower-level items and thus lower-items can be skipped. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response, a score > 4 indicates persistent hyper-tonus, and a score < 4 indicates various degrees of hypo-tonus
Modified Ashworth Scale
Changes from the Baseline this scale was measured Modified Ashworth Scale' scores exhibited better reliability when measuring upper extremities than lower[11]. The scale is as below: 0 No increase in muscle tone 1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 Considerable increase in muscle tone, passive movement difficult 4 Affected part(s) rigid in flexion or extension

Secondary Outcome Measures

Full Information

First Posted
February 27, 2020
Last Updated
April 20, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04289766
Brief Title
Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients
Official Title
Effects of Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
April 20, 2021 (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
Yes

5. Study Description

Brief Summary
Stroke is the second leading cause of death, accounting for 11.13 % of total deaths, and the main cause of disability worldwide. The major type of stroke is ischemic, which occurs in about 87% of all stroke cases Stroke has different risk factors, which can be grouped into modifiable and non-modifiable risk factors. Major risk factors for stroke include age, history of cerebrovascular event, smoking, alcohol consumption, physical inactivity, hypertension, diabetes mellitus, cardiovascular diseases, obesity, metabolic syndrome, diet, nutrition, and genetic risk factors. Many new technique used for rehabilitation after stroke includes Constraint-Induced Movement Therapy for Arm or Leg Paralysis, Mirror Therapy for Hand Recovery, Harness the Relentless Force etc. Segmental muscle vibration (SMV) is also a new technique and effective to decrease the hyper-toned muscles spasticity but still less work done on it. SMV with different frequencies have different effects for both flaccid and spastic patients of all 3 stages of stroke. In our study we will work with 60hz and 120hz frequencies to reduce the spasticity of upper limb and improves their functional level.
Detailed Description
Evidence strongly suggest that a period of pure sensory stimulation can affect motor corticoids activity excitability. In 2019 segmental muscle vibration(SMV) used to improve upper extremity functional ability post stroke and concluded that patients in both groups improved significantly after treatment in Barthel index (BI), elbow Range of Motion (ROM) and elbow muscle strength. However muscle tone in elbow joint of hemiplegic upper extremity improved significantly after only in the experimental group. They suggested that with routine physiotherapy with extended exposure SMV will results in significant reduced spasticity and better improved Activities Of Daily Livings (ADLs). In 2019 a work done with SMV to improve gate performance in patients with foot drop after chronic stroke. Results of this study revealed moderate improvement in mean gate speed, normal side swing velocity, bilateral stride length and normal-side toe off in experimental group. Further studies needed to evaluate the optimal and minimum SMV dosage. Another study conducted in 2019 to see Results show that processing speed, inhibitory control and attention improved following SMV. But working memory between groups and also not show a association between executive functions course and fall risk, so they suggest further work to examine effects of vibration therapy on executive functions. In 2014 another therapist highlight the potential use of SMV to modulate electromyographic (EMG) for reaching movement in chronic stroke patients but needs to be confirmed by larger control perspective trials of SMV. In 2019 combined work done with repetitive focal muscle vibration with physiotherapy to improve the motor function even in very acute phase of stroke and finds it a valid complementary non pharmacological therapy In 2019 another study suggest that Whole Body Vibration (WBV) and Upper and Lower Cycle (ULC) effective upper for upper extremity motor function and grip strength in sub-acute stroke. In 2019 a study reported the risk factors (vibration injury to hands vascular components, intermediate blanching neurological components and lower back pain for drivers of work machines) and benefits (improvement in bone health and neuromuscular function). So is a room for research to design a balanced WBV protocol. A study in 2018 did a meta-analysis and compare the effects of WBV in stroke patients and concludes that it is a safe therapeutic method for improving symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Subacute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm Description
Conventional Treatment includes exercises limbs
Arm Title
Focal Muscle Vibration (120Hz)
Arm Type
Experimental
Arm Description
Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 120 Hz. Conventional Treatment
Arm Title
Focal Muscle Vibration (60Hz)
Arm Type
Experimental
Arm Description
Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 60 Hz. Conventional Treatment
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
These individuals will receive the conventional intervention including the routine rehabilitation therapy like active and passive ROMs, stretching, strengthening of upper limb, balance improvement exercises. Time duration is of 40 minute 3 times per week.
Intervention Type
Other
Intervention Name(s)
Focal Muscle Vibration (120Hz)
Intervention Description
These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Focal Muscle Vibration (60Hz)
Intervention Description
These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.
Primary Outcome Measure Information:
Title
Fugl Meyer Scale (FMS)
Description
Changes from the Baseline this scale was measured Fugl Meyer Assessment is the utmost extensively used and approved clinical scale for assessment of sensorimotor loss in post stroke patients.This scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities) Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints) Balance (contains 7 tests, 3 seated and 4 standing) Joint range of motion (8 joints) Joint pain 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226. MAS detecting the changes in muscle tone in patients with stroke.. It's a 6 point scale. 0=no muscle tone, 4= affected parts rigid flexion or extension.Its reliability is 0.567.
Time Frame
Change from Baseline to 8 Weeks
Title
Motor Assessment Scale (MAS)
Description
Changes from the Baseline this scale was measured . The Motor Assessment Scale (MAS) is used to assess everyday motor function in patients with stroke. 8 items assess 8 areas of motor function Patients perform each task 3 times, only the best performance is recorded Items (with the exception of the general tonus item*) are assessed using a 7-point scale (0 to 6) A score of 6 indicates optimal motor behavior Item scores (with the exception of the general tonus item) are summed to provide an overall score (out of 48 points) Completing a higher-level item suggests successful performance on lower-level items and thus lower-items can be skipped. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response, a score > 4 indicates persistent hyper-tonus, and a score < 4 indicates various degrees of hypo-tonus
Time Frame
Change from Baseline to 8 Weeks
Title
Modified Ashworth Scale
Description
Changes from the Baseline this scale was measured Modified Ashworth Scale' scores exhibited better reliability when measuring upper extremities than lower[11]. The scale is as below: 0 No increase in muscle tone 1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 Considerable increase in muscle tone, passive movement difficult 4 Affected part(s) rigid in flexion or extension
Time Frame
Change from Baseline to 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemiplegic affected side spastic <3 on the Ashworth scale. History of stroke should be > 6 weeks and <12 weeks. Exclusion Criteria: Individuals with the other neurological deficit Diabetic ulcer, infection or amputation of limb Serious cardiovascular disease or unstable angina Serious orthopedic problem Chronic medical problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, Phd
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30762754
Citation
Annino G, Alashram AR, Alghwiri AA, Romagnoli C, Messina G, Tancredi V, Padua E, Mercuri NB. Effect of segmental muscle vibration on upper extremity functional ability poststroke: A randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14444. doi: 10.1097/MD.0000000000014444.
Results Reference
background
PubMed Identifier
19855076
Citation
Paoloni M, Mangone M, Scettri P, Procaccianti R, Cometa A, Santilli V. Segmental muscle vibration improves walking in chronic stroke patients with foot drop: a randomized controlled trial. Neurorehabil Neural Repair. 2010 Mar-Apr;24(3):254-62. doi: 10.1177/1545968309349940. Epub 2009 Oct 23.
Results Reference
background
PubMed Identifier
16680616
Citation
Smith L, Brouwer B. Effectiveness of muscle vibration in modulating corticospinal excitability. J Rehabil Res Dev. 2005 Nov-Dec;42(6):787-94. doi: 10.1682/jrrd.2005.02.0041.
Results Reference
background
PubMed Identifier
25227540
Citation
Paoloni M, Tavernese E, Fini M, Sale P, Franceschini M, Santilli V, Mangone M. Segmental muscle vibration modifies muscle activation during reaching in chronic stroke: A pilot study. NeuroRehabilitation. 2014;35(3):405-14. doi: 10.3233/NRE-141131.
Results Reference
background
PubMed Identifier
30873102
Citation
Toscano M, Celletti C, Vigano A, Altarocca A, Giuliani G, Jannini TB, Mastria G, Ruggiero M, Maestrini I, Vicenzini E, Altieri M, Camerota F, Di Piero V. Short-Term Effects of Focal Muscle Vibration on Motor Recovery After Acute Stroke: A Pilot Randomized Sham-Controlled Study. Front Neurol. 2019 Feb 19;10:115. doi: 10.3389/fneur.2019.00115. eCollection 2019.
Results Reference
background

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Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients

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