Neurodynamics on Spasticity in Upper Extremity of Stroke Patients.

Effects of Neurodynamics on Spasticity in Upper Extremity of Stroke Patients.

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Experimental group; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Riphah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Neurodynamics (Dynamic Neural Mobilization) with conventional treatment (stretching, AROM) will be applied.	Other: Experimental group; 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
Active Comparator: control group; Conventional treatment (stretching, AROM) will be applied	Other: Control group; Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6th weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6th weeks
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.	6th weeks
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.	6th week
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.	6th week
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.	6th Week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Mirza Obaid Baig, MS-NMPT, Riphah International University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): July 20, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Spasticity; Neurodynamics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: RiphahIU Nafeesa Zamurd

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No