StrokeNCT03822923
Neurodynamics on Spasticity in Upper Extremity of Stroke Patients.
A study testing Experimental group in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Jan 2019to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Modified Ashworth scale (MAS) of 1 to 3, chronic cases (6 -12 months)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Experimental group, Control group
- Keywords
- Neurodynamics, Spasticity, Stroke
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
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
Control groupOther
Conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Neurodynamics (Dynamic Neural Mobilization) with conventional treatment (stretching, AROM) will be applied. Receives: Other: Experimental group |
| control group | Active comparator | Conventional treatment (stretching, AROM) will be applied Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6th weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start23 Jan 2019
- Primary completion20 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822923
- Sponsor's protocol ID
- RiphahIU Nafeesa Zamurd
- Status last verified
- Sep 2019
- First submitted
- 28 Jan 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23449315Raid 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 at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurodynamics on Spasticity in Upper Extremity of Stroke Patients.
- ClinicalTrials.gov ID
- NCT03822923
- Acronym / sponsor ID
- RiphahIU Nafeesa Zamurd
- Conditions
- Stroke
- Keywords
- Neurodynamics, Spasticity, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupNeurodynamics (Dynamic Neural Mobilization) with conventional treatment (stretching, AROM) will be applied. |
| control group | Active comparator | Other: Control groupConventional treatment (stretching, AROM) will be applied |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Modified Ashworth scale (MAS) of 1 to 3, chronic cases (6 -12 months)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupNeurodynamics 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 | Other | Experimental group |
| Control groupConventional treatment | Other | control group |
Primary outcome
Modified Ashwarth Scale
Time frame: 6th weeks
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).
5 secondary outcomes
Range of motion Shoulder Joint (Flexion, Extension, abduction, internal rotation, external rotation )
Time frame: 6th weeks
Fugl Meyer upper extremity scale
Time frame: 6th weeks
Action research arm test (ARAT)
Time frame: 6th week
Range of motion of elbow joint ( flexion, extension, forearm Supination , Pronation)
Time frame: 6th week
Range of motion of Wrist joint (flexion, extension , ulnar deviation , thumb abduction )
Time frame: 6th Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- BackgroundSantana 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.
- BackgroundJeong 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.
- BackgroundAlan 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.
- Background: PubMed 23449315Villafane 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.
- BackgroundRaid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirza Obaid Baig, MS-NMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashwarth Scale (time frame: 6th weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822923, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.