History
# Registration date Revision Id
2 2024-08-24, 1403/06/03 316779
1 2023-09-27, 1402/07/05 280090
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  • General information

    empty
    Due to the inconsistency of the title of the trial with other parts of the study, it needed to be updated.
    empty
    باتوجه به عدم همخوانی عنوان کارآزمایی با سایر قسمت‌های مطالعه، نیازمند بروز رسانی بود.
    Evaluation of the effect of ultrasound therapy and nerve gliding techniques in patients with mild to moderate carpal tunnel syndrome
    The effect of combination of Alphalipoic acid and neuromuscular exercises on electrical activity of affected muscles in patients with multiple sclerosis.

Protocol summary

Study aim
Evaluation of the effect of ultrasound therapy and nerve gliding techniques in patients with mild to moderate carpal tunnel syndrome
Design
Clinical trial with a control group, with parallel groups, Single blind, randomized, phase 3 on 36 patients. The block method will be used for randomization.
Settings and conduct
This study is conducted in Razi Birjand Hospital, South Khorasan Province. 36 patients are randomly divided into three intervention groups one, two and three (A-C).
Participants/Inclusion and exclusion criteria
Our study population is patients with multiple sclerosis (MS) in Birjand city under treatment with rituximab. Subjects' inclusion criteria include: age between 20 and 45 years, relapsing and relapsing MS patients with severe disease activity who are treated with rituximab, - patients with disability grade 5.4 to 6; - Patients who are able to walk without help, patients who are able to walk at least 100 meters, and the criteria for leaving the subjects include: unwillingness of patients to cooperate with the research team, absence of more than 3 sessions in training sessions, lack of regular consumption Alpha lipoic acid drug and failure to answer phone calls to continue treatment.
Intervention groups
The patients examined in the study in one of three groups including: the first group receiving alpha lipoic acid supplement for 2 months in the form of 300 mg tablets twice a day (morning and night) (A), the second group receiving exercise Neuromuscular In a period of 8 weeks (3 days a week), 18 training stations are divided in a circle including static and dynamic exercises (B) and the third group receiving supplement + neuromuscular training (C).
Main outcome variables
Average kinematic parameters of lower limb joints (three-dimensional angles of ankle, knee and thigh joints), average performance variables (timed 7.5 meters walking, rising and walking tests)

General information

Reason for update
Due to the inconsistency of the title of the trial with other parts of the study, it needed to be updated.
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043934N21
Registration date: 2023-09-27, 1402/07/05
Registration timing: prospective

Last update: 2024-10-09, 1403/07/18
Update count: 1
Registration date
2023-09-27, 1402/07/05
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination of Alphalipoic acid and neuromuscular exercises on electrical activity of affected muscles in patients with multiple sclerosis.
Public title
The effect of alpha-ipoic acid supplementation along with neuromuscular training in the recovery of multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Relapsing and recovering MS patients with severe disease activity who are treated with rituximab patients with disability grade 4.5 to 6 Patients who are able to walk without assistance Patients who can walk at least 100 meters Age between 20 and 45 years
Exclusion criteria:
Unwillingness of patients to cooperate with the research team Absence of more than 3 sessions in practice sessions Not taking alpha lipoic acid medicine regularly Failure to answer the phone call to continue the treatment
Age
From 20 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 12
Randomization (investigator's opinion)
Randomized
Randomization description
Placement of people in each group randomly in one of three groups including: the first group receiving alpha lipoic acid supplement for 2 months in the form of 300 mg tablets twice a day (morning and night) (A), the second group receiving The recipient of neuromuscular training in a period of 8 weeks (3 days per week) will be divided into 18 training stations in a circle including static and dynamic exercises (B) and the third group receiving supplement + neuromuscular training (C). Then, first, various triple blocks (ABC, ACB, BAC, BCA, CAB, CBA) are created on different cards. One of these blocks will be randomly selected using the lottery method and the patients will be divided into one of three groups A, B or C. Then randomization is done for other patients as well. This will be done by the secretary.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluator: The study administrator will perform the necessary evaluation without knowing the type of intervention received by the patients and will be recorded in the checklist that was designed for this purpose.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.BUMS.REC.1401.307

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Average kinematic parameters of lower limb joints (three-dimensional angles of ankle, knee and thigh joints)
Timepoint
At the beginning of the study and before the start of interventions related to each group and 2 months after the relevant interventions, a necessary evaluation is done.
Method of measurement
The IMU device is used to check the three-dimensional angles of the ankle, knee and thigh joints.

2

Description
Average performance variables (7.5 meter walking, standing and timed walking tests)
Timepoint
The IMU device is used to check the three-dimensional angles of the ankle, knee and thigh joints.
Method of measurement
To evaluate the timed rise and walk test, the time taken for a person to stand up from a normal chair with a seat height of 45 cm (leaning on the back of the chair while the soles of his feet are on the floor and behind the marking line) Get up and walk a distance of three meters at your maximum safe speed and come back and sit back on the chair and lean back. It is recorded by a stopwatch. It is also used to evaluate the 7.5 meter walking test or the 25 foot test, a standard method to check the ability of patients to walk. MS is used by neurologists in such a way that patients are asked to cover a distance of 7.5 meters as quickly as possible, which usually should be done in less than 4 seconds in healthy people and patients who do not have significant mobility disabilities.

Secondary outcomes

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Intervention groups

1

Description
Intervention group: Intervention group 1: The receiving group received alpha lipoic acid supplement in the form of 300 mg tablets twice a day (morning and night) for 2 months.
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group 2: The recipient of neuromuscular training will perform 18 training stations in a circle including static and dynamic exercises in a period of 8 weeks (3 days per week).
Category
Treatment - Other

3

Description
Intervention group: Intervention group 3: receiving supplement + neuromuscular training for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurology Clinic of Razi Birjand Hospital
Full name of responsible person
Dr. Sadegh Mohammadnia Ahmadi
Street address
Neurology Clinic of Rzai Hospital , Ghafari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3136 6000
Email
razihospital@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Masoud Yosefi
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaqiq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
zabihullahmohaghegh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammad Mousavi mirzaie
Position
Member of the Faculty
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
mousavim903@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaqiq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd,
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
zabihullahmohaghegh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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