This study aims to assess the impact of dry needling on lower limb spasticity, motor performance, and range of motion among Paralympic athletes.
Design
A randomized, triple-blind, parallel groups controlled trial on 24 patients. Block randomization will be utilized for the randomization process.
Settings and conduct
Study location: Physiotherapy clinics of the Rehabilitation Faculty, Tehran University of Medical Sciences;
Study population: Paralympic athletes with spasticity;
Study design: Patients, assessor, statistical analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Athletes belonging to groups T35-T38 ccording to national Paralympic committee,
Age between 18 and 45 years,
consent to participate in the study
Exclusion criteria:
Individuals currently undergoing alternative treatments for spasticity or movement-related issues
Intervention groups
Intervention Group: Dry needling in the quadriceps and gastrocnemius muscles for one session using the Hong method.
Control Group: Sham needling in the quadriceps and gastrocnemius muscles for one session.
Main outcome variables
Spasticity in the quadriceps and gastrocnemius muscles using the Modified Ashworth Scale (MAS); Motor function using the Selective Control Assessment of the Lower Extremity (SCALE);Range of motion of the ankle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210811052141N2
Registration date:2024-05-19, 1403/02/30
Registration timing:registered_while_recruiting
Last update:2024-05-19, 1403/02/30
Update count:0
Registration date
2024-05-19, 1403/02/30
Registrant information
Name
Amin Nakhostin-Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7797 1942
Email address
a-nansari@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-10-23, 1403/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of dry needling compared to sham needle on spasticity and motor function in Paralympic Athletes
Public title
Effects of the dry needling on the the motor function of the athletes with movement impairment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Athletes in groups T35-T38 according to the International Paralympic Committee
Age between 18 and 45 years
Exclusion criteria:
Taking other treatments for spasticity or movement problems
Not giving consent to participate in the study
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The assigned interventions (12 dry needles and 12 placeboes) will be written on paper, and the papers will be placed in opaque envelopes. We will use stratified randomization methods to allocate the treatments. We will enroll 12 females and 12 males, and the participants will be stratified based on their gender; and within each stratum, three blocks will be used to allocate the interventions. Each block consists of a random set of equaled numbers of intervention and placebo.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Each patient will be assigned to a treatment or control group and unaware of the assigned group. The patients will go to the therapist with the envelopes and receive the assigned treatment. In addition, assessments will be performed by a physiotherapist who is unaware of the received treatment in patients. The data analyst will also be blind to the intervention received by participants. As both groups undergo treatment with needle, they will be unaware if the needle is dry needle or sham needle.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Neuroscience Institute
Street address
Neuroscience Institute, Imam Khomeini Hospital Complex, Gharib street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۳۹
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.TUMS.NI.REC.1400.025
Health conditions studied
1
Description of health condition studied
Spasticity in Paralympic athletes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Spasticity
Timepoint
Before intervention, immediately after intervention, 1 week after intervention
Method of measurement
Modified Ashworth Scale
2
Description
Motor function
Timepoint
Before intervention, immediately after intervention, 1 week after intervention
Method of measurement
Selective Control Assessment of the Lower Extremity Scale
3
Description
Range of motion
Timepoint
Before intervention, immediately after intervention, 1 week after intervention
Method of measurement
goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Dry needling; 3×50 mm Dong Bang needles using the Hong method will be applied to the taut bands in the gastrocnemius and quadriceps muscles and intervention is applied in one session.
Category
Rehabilitation
2
Description
Control group: Sham needle; sham needles will be used in one session on the gastrocnemius and quadriceps muscles.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Street address
School of Rehabilitation; Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Neuroscience Institute, Imam Khomeini Hospital Compelx, Gharib street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۳۹
Phone
+98 21 6658 1701
Email
tini@tums.ac.ir
Grant name
Grant code / Reference number
۵۱۶۹۱
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical 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
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
nakhostin@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
nakhostin@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
nakhostin@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data will become available upon deidentification.
When the data will become available and for how long
The data will be available upon the completion of the study.
To whom data/document is available
Other Researchers
Under which criteria data/document could be used
Data may be used for research purposes.
From where data/document is obtainable
Applicants should email prof. Nakhostin Ansari at nakhostin@tums.ac.ir
What processes are involved for a request to access data/document
The data will be will be available from the corresponding author upon reasonable request.