StrokeNCT05314465
Neural Mobilization for Reduction of Spasticity in Stroke
A study testing Median nerve mobilization in people with Stroke, run by Asir John Samuel at 3 sites in India.
Trial summary
Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult. There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Median nerve mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesIndia
- Study dates
- 22 Nov 2021to 15 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with subacute and chronic stroke (1month and above) having upper limb spasticity.
- Participants with haemorrhagic and ischemic stroke.
- Participants who tolerate the supine position.
- Participants who are oriented and alert.
- Both males and females.
- Participants older than 18 years.
Who cannot join
- Participants with a score greater than 3 on The Modified Ashworth Scale.
- Participants with affected speech.
- Participants with upper limb deformity.
- Participants experiencing dizziness.
- Any increase in the dosage of anti-spastic medications during the intervention period.
- General health problems or pathologies that affect the nervous system like uncontrolled diabetes, hypertension and recent surgeries.
- Recent onset of worsening neurological signs.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation
Ambāla, Haryana, 133207
Healing Hands Physiotherapy & Rehabilitation
Hisar, Haryana, 125001
Bedi Hospital
Kaithal, Haryana, 136027
About this study
Official title: Effectiveness of Neural Mobilization on Spasticity and Upper Limb Function in Individuals With Stroke
Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult. There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength. This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke. This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated). Median nerve mobilization was given 20 oscillations per minute for 3 times \& repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks. Outcome measures were Modified Ashworth Scale (MAS), Brunnstrom's grading of hand recovery and Hydraulic hand dynamometer(HHD) for grip and pinch strength. Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength.
Read the detailed description
Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult. There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength. This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke. This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated). Median nerve mobilization was given 20 oscillations per minute for 3 times \& repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks. Primary outcome measure was Modified Ashworth Scale (MAS) to assess elbow and wrist flexors spasticity and secondary outcome measures were Brunnstrom's stages for hand recovery and Hydraulic hand dynamometer(HHD) to measure grip and pinch strength. Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength.
- Conditions
- Stroke
- Being tested
- Median nerve mobilization
- Keywords
- Stroke, spasticity, neural mobilization, Upper limb
- 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.
Median nerve mobilizationOther
Median nerve mobilization was given 20 oscillations per minute for 3 times \& repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks.
| Study group | Role | What they receive |
|---|---|---|
| Median nerve mobilization | Experimental | Experimental arm given Median nerve mobilization for 12mins 3sets for 3mins each with 1 minute interval in between for 5times a week for 4weeks Receives: Other: Median nerve mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
For spasticity, Total 4 grades are there. Grade 0 means no increase in muscle tone and grade 4 means affected part rigid in flexion or extension. More grade means more spasticity is there.
Measured: Change from baseline and 4 weeks
Secondary outcomes (2)
Brunnstrom's stages for hand recovery
To check recovery of hand functions. Total 7 grades are there. Increase in grade means increase in hand functions.
Measured: Change from baseline and 4 weeks
Hydraulic hand dynamometer
For grip and pinch strength
Measured: Change from baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start22 Nov 2021
- Primary completion19 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Rittu Sharma, (MPT), Principal investigator, Maharishi Markandeshwar Institute of Physiotherapy and RehabilitationAsir John Samuel, Ph.D, Study chair, Maharishi Markandeshwar Institute of Physiotherapy and RehabilitationAkanksha Saxena, (Ph.D), Study director, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314465
- Sponsor's protocol ID
- MMDU/IEC/1935
- Other IDs
- U1111-1276-6515
- Status last verified
- Aug 2022
- First submitted
- 30 Mar 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neural Mobilization on Spasticity and Upper Limb Function in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT05314465
- Acronym / sponsor ID
- MMDU/IEC/1935
- Conditions
- Stroke
- Keywords
- Stroke, spasticity, neural mobilization, Upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 19 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 6 Apr 2022 (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.
Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult. There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength. This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke. This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated). Median nerve mobilization was given 20 oscillations per minute for 3 times \& repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks. Outcome measures were Modified Ashworth Scale (MAS), Brunnstrom's grading of hand recovery and Hydraulic hand dynamometer(HHD) for grip and pinch strength. Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength.
Detailed description
Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult. There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength. This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke. This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated). Median nerve mobilization was given 20 oscillations per minute for 3 times \& repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks. Primary outcome measure was Modified Ashworth Scale (MAS) to assess elbow and wrist flexors spasticity and secondary outcome measures were Brunnstrom's stages for hand recovery and Hydraulic hand dynamometer(HHD) to measure grip and pinch strength. Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Median nerve mobilization | Experimental | Other: Median nerve mobilizationExperimental arm given Median nerve mobilization for 12mins 3sets for 3mins each with 1 minute interval in between for 5times a week for 4weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with subacute and chronic stroke (1month and above) having upper limb spasticity.
- Participants with haemorrhagic and ischemic stroke.
- Participants who tolerate the supine position.
- Participants who are oriented and alert.
- Both males and females.
Key exclusion criteria (7 listed)
- Participants with a score greater than 3 on The Modified Ashworth Scale.
- Participants with affected speech.
- Participants with upper limb deformity.
- Participants experiencing dizziness.
- Any increase in the dosage of anti-spastic medications during the intervention period.
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 |
|---|---|---|
| Median nerve mobilizationMedian nerve mobilization was given 20 oscillations per minute for 3 times \& repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks. | Other | Median nerve mobilization |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: Change from baseline and 4 weeks
For spasticity, Total 4 grades are there. Grade 0 means no increase in muscle tone and grade 4 means affected part rigid in flexion or extension. More grade means more spasticity is there.
2 secondary outcomes
Brunnstrom's stages for hand recovery
Time frame: Change from baseline and 4 weeks
Hydraulic hand dynamometer
Time frame: Change from baseline and 4 weeks
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 17 Aug 2022.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Rittu Sharma, (MPT) principal investigator
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Asir John Samuel, Ph.D study chair
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Akanksha Saxena, (Ph.D) study director
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Median nerve mobilization in people with Stroke, run by Asir John Samuel at 3 sites in India.
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 6 inclusion and 7 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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 Ashworth Scale (MAS) (time frame: Change from baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2022.