Protocol summary
-
Study aim
-
Effects of one session dry needling on balance dysfunction, plantar flexor and inverter muscles spasticity, active and passive ankle range of motion, and limb motor function in patients with stroke.
-
Design
-
The clinical trial includes two intervention and control groups, each with a sample size of 11 people, in a parallel grouping form, in a double-blind manner, and with an accessible and randomized sampling method in the grouping.
-
Settings and conduct
-
The field of this study is the treatment (rehabilitation) of stroke patients. Patients are referred to Isfahan Rehabilitation Faculty Research Center by neurologists. Consent forms and questionnaires will be obtained from the patients after necessary briefings are provided on the objectives, implementation method, and confidentiality of the patients' information. Then related evaluations and intervention are done. The intervention includes real and sham dry needling. In this study, the outcome evaluator as well as the participants are blindly unaware of the placement of patients in each of the intervention and sham groups.
-
Participants/Inclusion and exclusion criteria
-
Stroke patients with at least six months after their lesion’s onset.
-
Intervention groups
-
Intervention group: Patients in the test group will receive one session of dry needling treatment in the flexor and invertor muscles of the foot. Each volunteer undergoes a dry needling treatment session. Control group: The intervention in the control group will include receiving a sham needle session. In this group, the intervention method is exactly the same as the test group, with the difference that the needle will not pierce the skin. For this purpose, special needles are used. These needles have the same tube as standard needles, but the needle is blunt and does not penetrate the skin.
-
Main outcome variables
-
Balance dysfunction, spasticity
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20221228056963N1
Registration date:
2023-02-03, 1401/11/14
Registration timing:
prospective
Last update:
2024-07-12, 1403/04/22
Update count:
1
-
Registration date
-
2023-02-03, 1401/11/14
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2023-02-04, 1401/11/15
-
Expected recruitment end date
-
2023-07-06, 1402/04/15
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Effects of one session dry needling on balance dysfunction, plantar flexor and inverter muscles spasticity, ankle active and passive range of motion, and limb motor function in patients with stroke
-
Public title
-
Effects of dry needling in patients with stroke
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Having a stroke
Age 45 to 75 years
Spasticity in the plantar flexor and invertor muscles grade 1 or higher on the MMAS scale
Ability to stand independently
Not taking anti-spasticity drugs and not injecting Botox in the last six months
Not suffering from other neurological diseases
Not having any kind of fracture and surgery in the lower limb
Absence of contraindications for dry needling treatment
Exclusion criteria:
Presence of fixed deformity in the involved ankle of the patient
Reluctance to continue treatment
Cases of non-use of dry needling
-
Age
-
From 45 years old to 75 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
22
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomization will be done using Randomization.com website. In this method, according to the intervention (a) and control (b) groups, a block of 4 is determined. Then each sequence is placed on a registration card and inside an envelope. When each patient enters, one of the envelopes is opened and the group assigned to that participant is determined. In this double-blind study, patients and evaluators are unaware of the type of assigned group. Randomization and intervention will be done by a person who is not involved in the evaluation process of patients and the evaluator is also unaware of the type of intervention.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
In this study, the outcome evaluator as well as the participants are double-blinded. Since the intervention in the test group is done with real dry needling and in the control group with sham dry needling, the patients will not notice the difference in the appearance of the two types of main dry needling and sham dry needling.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2022-12-20, 1401/09/29
-
Ethics committee reference number
-
IR.USWR.REC.1401.189
Health conditions studied
1
-
Description of health condition studied
-
Stroke
-
ICD-10 code
-
G46
-
ICD-10 code description
-
Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
-
Description
-
Evaluation of static balance indicators
-
Timepoint
-
Before and after intervention - One week later - One month later
-
Method of measurement
-
Force plate device
2
-
Description
-
Evaluation of spasticity
-
Timepoint
-
Before and after intervention - One week later - One month later
-
Method of measurement
-
Modified modified Ashworth scale
Secondary outcomes
1
-
Description
-
Evaluation of dynamic balance indicators
-
Timepoint
-
Before and after of intervention - One week later - One month later
-
Method of measurement
-
Time up and go test
2
-
Description
-
Evaluation of active and passive range of motion of the ankle
-
Timepoint
-
Before and after of intervention - One week later - One month later
-
Method of measurement
-
Goniometer
3
-
Description
-
Functional evaluation of the lower limb
-
Timepoint
-
Before and after of intervention - One week later - One month later
-
Method of measurement
-
Brunnstrom scale
Intervention groups
1
-
Description
-
Intervention group: Patients in the test group will receive one session of dry needling treatment in the flexor and invertor muscles of the foot (gastrocnemius, soleus and posterior tibialis). Each volunteer undergoes a dry needling treatment session. In this study, a needle with dimensions of 50 x 0.3 mm will be used. The needle will be moved in the muscles in a conical way and for one minute as Fast in-Fast out.
-
Category
-
Rehabilitation
2
-
Description
-
Control group: The intervention in the control group will include receiving a sham needle session. In this group, the intervention method is exactly the same as the test group, with the difference that the needle will not pierce the skin. For this purpose, special needles are used. These needles have the same tube as standard needles, but the needle is blunt and does not penetrate the skin.
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
University of social welfare and rehabilitation sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
Currently, no decision has been made for publication.
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available