Comparison of the effect of dry needling with and without exercise therapy on wrist flexors spasticity, motor function and motor neuron excitability in patients with chronic stroke: a double-blind randomized clinical trial
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.
Design
A double-blind randomized clinical trial with parallel groups and three-week follow-up.
Randomization is done by throwing coins.
Sample size was 12 patients in each groups according to the results of similar studies using G power software.
Settings and conduct
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 the coining a toss. The treatment group will receive the dry needle with the exercise therapy and the control group only receive 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 evaluation. Patients did not know whether they are in the intervention or in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Documented diagnosis of stroke by a neurologist;
At least 6 months have passed since the stroke;
Age range of 40 to 65 years;
being the first time stroke leading to hemiplegia;
Spasticity greater than one for wrist flexor muscles based on MMAS scale.
Exclusion criteria:
Having contracture in hand;
Contraindication for dry needling
Intervention groups
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)
Main outcome variables
Wrist flexor spasticity; motor neuron excitability; motor function; wrist extension range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180611040061N1
Registration date:2020-05-17, 1399/02/28
Registration timing:registered_while_recruiting
Last update:2020-05-17, 1399/02/28
Update count:4
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Seyedeh Saeideh Babazadeh-Zavieh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3376 1431
Email address
babazadehpt89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dry needling with and without exercise therapy on wrist flexors spasticity, motor function and motor neuron excitability in patients with chronic stroke: a double-blind randomized clinical trial
Public title
Effect of dry needling with exercise therapy on stroke spasticity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Documented diagnosis of stroke by a neurologist
At least 6 months have passed since the stroke
Age range of 40 to 65 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
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The therapist randomly determines the presence of the patient in the treatment or control group by throwing a coin
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-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.
On the other hand, by giving a separate questionnaire to each patient in two groups, they will not know whether they are in the intervention group or in the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
School of Rehabilitation Sciences, Enghelab Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.TUMS.FNM.REC.1399.008
Health conditions studied
1
Description of health condition studied
Chronic stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Wrist flexors spasticity
Timepoint
Measurement of Spasticity before and after the intervention (4 weeks after intervention) and 3 weeks after the intervention
Method of measurement
Persian version of Modified Modified Ashworth Scale
2
Description
Alpha motor neuron excitability
Timepoint
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
Method of measurement
Electromyography machine (EMG)
3
Description
Motor function
Timepoint
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
Method of measurement
Study of patients motor function with Fugl-Meyer Scale and Action Research Arm Test
Secondary outcomes
1
Description
Range of motion
Timepoint
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
Method of measurement
Goniometer
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian hospital
Full name of responsible person
Seyed Abbas Motavalian
Street address
میدان بهارستان، خیابان مجاهدین اسلام، بیمارستان شفایحیائیان