Protocol summary
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Study aim
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Evaluation of the effect of ultrasound therapy and nerve gliding techniques in patients with mild to moderate carpal tunnel syndrome
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Design
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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.
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Settings and conduct
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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).
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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).
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Main outcome variables
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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
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Reason for update
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Due to the inconsistency of the title of the trial with other parts of the study, it needed to be updated.
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Acronym
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IRCT registration information
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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
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Registration date
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2023-09-27, 1402/07/05
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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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2023-10-07, 1402/07/15
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Expected recruitment end date
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2023-11-06, 1402/08/15
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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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The effect of combination of Alphalipoic acid and neuromuscular exercises on electrical activity of affected muscles in patients with multiple sclerosis.
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Public title
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The effect of alpha-ipoic acid supplementation along with neuromuscular training in the recovery of multiple sclerosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 45 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
12
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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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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2022-11-07, 1401/08/16
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Ethics committee reference number
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IR.BUMS.REC.1401.307
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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Average kinematic parameters of lower limb joints (three-dimensional angles of ankle, knee and thigh joints)
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Timepoint
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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.
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Method of measurement
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The IMU device is used to check the three-dimensional angles of the ankle, knee and thigh joints.
2
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Description
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Average performance variables (7.5 meter walking, standing and timed walking tests)
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Timepoint
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The IMU device is used to check the three-dimensional angles of the ankle, knee and thigh joints.
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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).
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Category
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Treatment - Other
3
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Description
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Intervention group: Intervention group 3: receiving supplement + neuromuscular training for 8 weeks.
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Category
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Treatment - Drugs
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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Birjand 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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