Protocol summary
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Study aim
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The purpose of this study was to compare the effect of dry needle with and without exercise therapy on wrist flexor spasticity, motor function and motor neuron excitability in patients with chronic stroke.
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Design
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A single-blind randomized clinical trial with parallel groups and three-week follow-up.
Randomization will be done by selecting the opaque envelopes.
The sample size was 12 patients in each group according to the results of similar studies using G power software.
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Settings and conduct
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Patients who meet the inclusion criteria will be recalled from neurosurgery clinics. After initial evaluations, patients will be randomly assigned to the control and treatment groups by selecting the opaque envelopes by the secretary of the clinic . The treatment group will receive the dry needle with the exercise therapy and the control group only receive the dry needle. Treatment will be performed once a week for 4 weeks and assessments are performed again after 4 weeks as well as after a 3-week follow-up. One experienced physiotherapist will perform the assessments and the other will perform the evaluation.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Documented diagnosis of stroke by a neurologist;
At least 6 months have passed since the stroke;
Age over 40 years;
being the first time stroke leading to hemiplegia;
Spasticity greater than one for wrist flexor muscles based on the MMAS scale.
Exclusion criteria:
Having contracture in hand;
Contraindication for dry needling
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Intervention groups
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Intervention group: Dry needling with exercise therapy. 4 sessions exercise therapy after dry needle (onse a week)
Control group: Dry needling. 4 sessions dry neddling (once a week)
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Main outcome variables
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Wrist flexor spasticity; motor neuron excitability; motor function; wrist extension range of motion
General information
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Reason for update
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Due to the exercise therapy intervention, blinding patients will not be feasible in this study. Therefore, the blind section and the title of the study were edited and modified.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180611040061N1
Registration date:
2020-05-17, 1399/02/28
Registration timing:
prospective
Last update:
2022-01-09, 1400/10/19
Update count:
4
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Registration date
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2020-05-17, 1399/02/28
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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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2020-11-20, 1399/08/30
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Expected recruitment end date
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2022-06-20, 1401/03/30
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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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Effects of Dry Needling and Exercise Therapy on Post-Stroke Spasticity and Motor Function– A Randomized Clinical Trial
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Public title
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Effect of dry needling with exercise therapy on stroke spasticity
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Documented diagnosis of stroke by a neurologist
At least 6 months have passed since the stroke
Age>40 years
Being the first time stroke leading to hemiplegia
Spasticity greater than one for wrist flexor muscles based on MMAS scale
Absence of sensory disorders, bleeding, upper limb malignancies, ulcers and infection
Ability to understand therapist and evaluator instructions
Full consent to participate in the research
Exclusion criteria:
Fear of applying dry needles
Having contracture in hand
Contraindication for dry needling
Other neurological lesions
Having Diabetes
Any history of treatment with nerve blockers such as botulinum toxin A 6 months prior to inclusion
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Age
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From 40 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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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In order to randomly assign the patients, the opaque envelopes will be prepared containing the assigned terms "dry needling" or "dry needling+ exercise therapy" interventions. The secretary of the clinic will be choosing an envelope randomly.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This is a single-blind clinical trial in which a expert physiotherapist will perform intervention and other physiotherapists will perform the Assessment. As a result, the Assessor will not know which group the patient belongs to.
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Placebo
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Not 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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2020-04-28, 1399/02/09
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Ethics committee reference number
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IR.TUMS.FNM.REC.1399.008
Health conditions studied
1
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Description of health condition studied
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Chronic 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, unspecified
Primary outcomes
1
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Description
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Wrist flexors spasticity
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Timepoint
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Measurement of Spasticity before and after the intervention (4 weeks after intervention) and 3 weeks after the intervention
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Method of measurement
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Persian version of Modified Modified Ashworth Scale
2
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Description
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Alpha motor neuron excitability
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Timepoint
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Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
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Method of measurement
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Electromyography machine (EMG)
Secondary outcomes
1
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Description
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Range of motion
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Timepoint
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Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
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Method of measurement
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Goniometer
2
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Description
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Motor function
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Timepoint
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Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
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Method of measurement
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Study of patients motor function with Fugl-Meyer Scale and Action Research Arm Test
Intervention groups
1
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Description
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Intervention group: In the treatment group, patients will receive exercise therapy in addition to dry needle. Immediately after dry needle, patients will do exercises in Structure, Function, and Activity levels to mobilize wrist and finger joints to relieve muscle strength imbalance and gain motor control of affected limb and improve performance for 30 to 45 minutes, once a week, for a total of 4 weeks. The same exercises will be performed once a day at home and if they are unable to fully perform each exercise, the therapist in the clinic and a person at home will help the patients.
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Category
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Rehabilitation
2
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Description
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Control group: The control group will only receive dry needle intervention. Dry needle treatment will be administered once a week for 4 weeks. Patients in this group will continue their previous activities throughout life without any changes.
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Category
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Rehabilitation
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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Tehran University of Medical 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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Yes - There is 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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Undecided - It is not yet known if there will be a plan to make this available
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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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If needed by researchers and their request, the raw data of research and it's analysis will be available to researchers
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When the data will become available and for how long
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After the publication of articles resulting from the research
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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The data are available only to other researchers to study and evaluate treatment outcomes.
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From where data/document is obtainable
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By sending an email to the corresponding author
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What processes are involved for a request to access data/document
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Email the corresponding author and request the data
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Comments
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