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Neurodynamics on Spasticity in Upper Extremity of Stroke Patients.

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Neurodynamics, Spasticity, Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Modified Ashworth scale (MAS) of 1 to 3, chronic cases (6 -12 months)

Exclusion Criteria:

  • Modified Ashworth scale (MAS) 0 and 4, painfull upper extremity, orthopedic problem (e.g fracture)
  • In upper extremity, UMNL other than stroke,
  • Any signs of inflammation, infection or malignancy

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

control group

Arm Description

Neurodynamics (Dynamic Neural Mobilization) with conventional treatment (stretching, AROM) will be applied.

Conventional treatment (stretching, AROM) will be applied

Outcomes

Primary Outcome Measures

Modified Ashwarth Scale
Effects of neurodynamics to reduce spasticity in uppper extremity will be assesed through Modified Ashwarth Scale changes from Baseline. Modified Ashwarth Scale is a specific scale to asses spasticity. Scoring is done from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).

Secondary Outcome Measures

Range of motion Shoulder Joint (Flexion, Extension, abduction, internal rotation, external rotation )
Changes from the baseline. Range of Motion of Shoulder will be Assess through Goniometer.
Fugl Meyer upper extremity scale
Changes from the Baseline. Fugl Meyer is a stroke specific, performance based impairment index designed to assess motor functioning, sensation and joint functioning. The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. FMUE Scale scores < 31 corresponded with 'no to poor' upper extremity capacity, while 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity.
Action research arm test (ARAT)
Changes from the baseline. Action research arm test is highly reliable and valid 19 items tool (grasp (6 items), grip(4 items), pinch (6 items) and gross movement (3 items) which is used to asses upper extremity performance (coordination, dexterity and functioning). In ARAT scoring is done from 0 (unable to complete) to 3 (complete with normal movement). Scores on the ARAT range from 0-57 points, with a maximum score of 57 points indicating better performance. The ARAT can be used to predict the functional recovery of the upper extremity in stroke rehabilitation. Scores of less than 10 points, between 10-56 points, and 57 points correlate with poor, moderate, and good recovery respectively.
Range of motion of elbow joint ( flexion, extension, forearm Supination , Pronation)
Changes from the baseline. Range of Motion of Elbow joint will be Assess through Goniometer.
Range of motion of Wrist joint (flexion, extension , ulnar deviation , thumb abduction )
Changes from the baseline Range of Motion of wrist joint will be Assess through Goniometer.

Full Information

First Posted
January 28, 2019
Last Updated
September 5, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT03822923
Brief Title
Neurodynamics on Spasticity in Upper Extremity of Stroke Patients.
Official Title
Effects of Neurodynamics on Spasticity in Upper Extremity of Stroke Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
July 20, 2019 (Actual)
Study Completion Date
July 31, 2019 (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
Data will be collected from 40 patients with hemiplegia, caused by stroke from DHQ hospital Jhelum. its an RCT Neurodynamics with conventional treatment to experimental group and conventional treatment alone to control group will be applied for 6 weeks. Simple random sampling will be done and randomization will be done through tossing a coin. Intervention wil be applied and assesment will be done through fugl-meyer upper extremity scale, Modified Aashwarth scale,goniometry and action research arm test at zero, 3rd and 6th week.
Detailed Description
Informed consent was taken and patients were assessed for eligibility and patients who meet the inclusion criteria were randomized through simple random sampling into experimental and control group. Zero, 3rd and 6th week assessment was done through Action research arm test to assess upper limb performance, Goniometry to assess range of motion, Fugl-meyer upper extremity scale FMUE to assess motor functioning, sensation and joint functioning and modified ashworth scale MAS to assess spasticity. Intervention was applied for 6 weeks. The intervention in control group (n=23) was conventional treatment which includes stretching (static stretching for 20 sec) and range of motion exercises (within limit of range) . Intervention was administered one set per day (12 reps per set) four repetitions for each movement direction for 3 days a week, over a course of 6 weeks. The intervention in experimental group (n=23) was conventional treatment which includes stretching (static stretching for 20 sec) and range of motion exercises (within limit of range) with neurodynamics (Dynamic neural mobilization technique) which includes median, ulnar and radial nerve mobilization. Peripheral nerve was stretched for 20 sec with addition of dynamic movement which was performed after every 2 sec for a total of 20 sec. Neurodynamics was administered, one set per day (10 rep per set) , for 3 days a week, over a course of 6 weeks. Normality of data was checked through shapiro wilk test as sample size is <50 and parametric or non-parametric tests were applied accordingly through SPSS version 21. Rhythmic neurodynamics accelerated the nerve conduction velocity more than the general neurodynamics. Positive effect of neurodynamics to reduce tone, increase range and improve function of stroke patients were determined in 2016. Combination of neural mobilization and Botulinum toxin-A is effective to reduce pain and increase ranges of motion.Decrease in anxiety also occurs. Botulinum toxin inhibits release of acetylcholine causing a blockade of the neuromuscular patches without affecting the antagonist muscles resulting in reduced spasticity. Neural mobilization is effective than conventional neural mobilization to increase β-waves and decrease μ-rhythms in C3 and C4 areas of cerebral cortex (primary motor areas). Neural mobilization was effective for improving range of motion of shoulder joint in all degree of freedom by reducing muscle tension and increasing extensibility of neural tissue. Neural mobilization is effective to reduce spasticity in bicep brachii muscle. Decrease in myoelectric activity is the mechanism behind reduction of tone in stroke patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Neurodynamics, Spasticity, Stroke

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Neurodynamics (Dynamic Neural Mobilization) with conventional treatment (stretching, AROM) will be applied.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Conventional treatment (stretching, AROM) will be applied
Intervention Type
Other
Intervention Name(s)
Experimental group
Intervention Description
Neurodynamics with conventional treatment. Intervention will be applied for 6 weeks (10 reps per set, 1 set per day, 3 days per week) for 30 minutes
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Conventional treatment
Primary Outcome Measure Information:
Title
Modified Ashwarth Scale
Description
Effects of neurodynamics to reduce spasticity in uppper extremity will be assesed through Modified Ashwarth Scale changes from Baseline. Modified Ashwarth Scale is a specific scale to asses spasticity. Scoring is done from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
Time Frame
6th weeks
Secondary Outcome Measure Information:
Title
Range of motion Shoulder Joint (Flexion, Extension, abduction, internal rotation, external rotation )
Description
Changes from the baseline. Range of Motion of Shoulder will be Assess through Goniometer.
Time Frame
6th weeks
Title
Fugl Meyer upper extremity scale
Description
Changes from the Baseline. Fugl Meyer is a stroke specific, performance based impairment index designed to assess motor functioning, sensation and joint functioning. The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. FMUE Scale scores < 31 corresponded with 'no to poor' upper extremity capacity, while 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity.
Time Frame
6th weeks
Title
Action research arm test (ARAT)
Description
Changes from the baseline. Action research arm test is highly reliable and valid 19 items tool (grasp (6 items), grip(4 items), pinch (6 items) and gross movement (3 items) which is used to asses upper extremity performance (coordination, dexterity and functioning). In ARAT scoring is done from 0 (unable to complete) to 3 (complete with normal movement). Scores on the ARAT range from 0-57 points, with a maximum score of 57 points indicating better performance. The ARAT can be used to predict the functional recovery of the upper extremity in stroke rehabilitation. Scores of less than 10 points, between 10-56 points, and 57 points correlate with poor, moderate, and good recovery respectively.
Time Frame
6th week
Title
Range of motion of elbow joint ( flexion, extension, forearm Supination , Pronation)
Description
Changes from the baseline. Range of Motion of Elbow joint will be Assess through Goniometer.
Time Frame
6th week
Title
Range of motion of Wrist joint (flexion, extension , ulnar deviation , thumb abduction )
Description
Changes from the baseline Range of Motion of wrist joint will be Assess through Goniometer.
Time Frame
6th Week

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: Modified Ashworth scale (MAS) of 1 to 3, chronic cases (6 -12 months) Exclusion Criteria: Modified Ashworth scale (MAS) 0 and 4, painfull upper extremity, orthopedic problem (e.g fracture) In upper extremity, UMNL other than stroke, Any signs of inflammation, infection or malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MS-NMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Santana AL. Efeito da mobilização neural na amplitude articular do ombro em pacientes acometidos com acidente vascular encefálico. Revista Inspirar: movimento & saúde. 2013; (5)6:7-10.
Results Reference
background
Citation
Jeong Kang et al, The Effects of Rhythmic Neurodynamic on the Upper Extremity Nerve Conduction Velocity and the Function for Stroke Patients, JKPT 2017, Volume 29 No. 4.
Results Reference
background
Citation
Alan Carlos Nery dos Santos et al, The effects of neural mobilization as a therapeutic option in the treatment of stroke, MTP and Rehab journal 2017, ISSN 2236-5435.
Results Reference
background
PubMed Identifier
23449315
Citation
Villafane JH, Silva GB, Chiarotto A, Ragusa OL. Botulinum toxin type A combined with neurodynamic mobilization for upper limb spasticity after stroke: a case report. J Chiropr Med. 2012 Sep;11(3):186-91. doi: 10.1016/j.jcm.2012.05.009.
Results Reference
background
Citation
Raid Saleem Al Baradie et al, The effects of Neurodynamics and mobilization in Stroke Rehabilitation- a Systematic Review, Majmaah Journal of Health Sciences 2017, Vol.5, issue 2.
Results Reference
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Neurodynamics on Spasticity in Upper Extremity of Stroke Patients.

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