Protocol summary
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Study aim
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Determine to effect of dry needling on spasticity, consistency of corticospinal tract and function of upper extremity in subjects with stroke.
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Design
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A clinical trial, double-blind, placebo-controlled clinical trial will be performed
using sample of convenience and sample size of 10 individuals in each
group.
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Settings and conduct
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Dry needling will be performed using a sterilized, stainless, disposable nipple with a size of 0.25 mm 0.30 mm. Patients are in supine position,the arm is far from the trunk and elbow in supination . The technique used is fast in-fast out for each muscle for one minute.
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Participants/Inclusion and exclusion criteria
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Patients who 1) at least six month have passed since their stroke2) have had only one stroke 3) MMAS test is one to three, 3) Did not use any anti-spasticity medication 24 hours before of intervention will be included. People with dry needle contraindications, or any other neurological disease, or having a fixed muscle contraction in the wrist will be excluded.
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Intervention groups
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In the intervention group ( Dry needling): Wrist flexor muscles (flexor carpi ulnaris and flexor carpi radialis) were considered for needling . So patients undergo 3 sessions (every other day) deep needling for the affected wrist flexor muscles.
In control group( sham dry needling),Instead of dry needles, sham needles will be used for the same muscles as above. Sham needle has a thick edge that without irritating the skin only stimulates the skin.
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Main outcome variables
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The outcome measures include severity of spasticity by MMAS will be measurerd), consistency of CST which evaluated by DTI) and hand dexterity which will measured by BBT), and active and passive ROM that will be assessed by goniometer) before and after of treatment in both groups.
General information
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Reason for update
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Unfortunately, due to the corona pandemic, the start of data collecting of patient was delayed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191208045649N1
Registration date:
2020-06-12, 1399/03/23
Registration timing:
prospective
Last update:
2021-07-08, 1400/04/17
Update count:
2
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Registration date
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2020-06-12, 1399/03/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-08-22, 1400/05/31
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Expected recruitment end date
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2022-09-20, 1401/06/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect Of Dry Needling on Spasticity, consistency of Corticospinal Tract and Function of Upper Extremity In Subject with Stroke
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Public title
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Effect Of Dry Needling on Spasticity, consistency of Corticospinal Tract and Function of Upper Extremity In Subject with Stroke
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Purpose
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Basic scienece
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Inclusion/Exclusion criteria
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Inclusion criteria:
disease duration of at least six months
first ever stroke
wrist flexor MMAS spasticity score 1 up to 3
Taking no antispastic drug 24 hour before of the entrance to study
Exclusion criteria:
contraindications to Dry Needling
presence of any other neurological disorder
Fixed muscle contractures at the wrist joint
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
106
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be divided into intervention or control groups according to the stratified permuted block randomization method.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Treatment will be performed by a trained therapist. The evaluation is performed by another physiotherapist who is unaware of the grouping and treatment process of the patients. Patients will also be unaware of the grouping.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-24, 1398/09/03
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Ethics committee reference number
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IR.USWR.REC.1398.149
Health conditions studied
1
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Description of health condition studied
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Stroke
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ICD-10 code
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I63.9
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ICD-10 code description
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Cerebral infarction
Primary outcomes
1
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Description
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Consistency corticospinal tract by fractional anisotropy value severity of spasticity
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Timepoint
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One day before the intervention and one day after the third intervention session
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Method of measurement
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Corticospinal tract imaging device OR Difussion tensor imaging MMAS
Secondary outcomes
1
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Description
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Wrist active ROM EXT Dexterity of hand
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Timepoint
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One day before intervention and on day after end of intervention
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Method of measurement
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Goniometer
2
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Description
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Wrist passive ROM EXT
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Timepoint
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One day before intervention and on day after end of intervention
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Method of measurement
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Goniometer
3
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Description
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Hand dexterity
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Timepoint
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One day before intervention and on day after end of intervention
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Method of measurement
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Box and Block test
Intervention groups
1
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Description
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Intervention group: The study included wrist flexor muscles (carpal ulnaris flexor and carpi radialis flexor). Patients underwent 3 sessions for (every other day) for deep wrist flexion of the affected wrist muscles. The technique used is fast in-fast out for each muscle for one minute.
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Category
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Rehabilitation
2
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Description
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Control group: Instead of dry needles, sham needles will be used for the same muscles as above. Sham needles have a thick edge that only irritates the skin without piercing the skin.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of social welfare and rehabilitation sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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demographic data and primary and secondary out come measures can be shared
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When the data will become available and for how long
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starting 6 months after publication
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To whom data/document is available
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only available for people working in academic institutions
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Under which criteria data/document could be used
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any use of data must be in coordination with authors
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From where data/document is obtainable
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Iraj Abdolllahi
Irajabdollahi@hotmail.com
Masoome Ebrahimzadeh ,coworker
masoome.Ebrahimzadeh@gmail.com
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What processes are involved for a request to access data/document
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a request must be send to email address and if it will be approved , the files will be send.
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Comments
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