Comparing the effect of mental exercise and routine occupational therapy on balance and walking performance among patients suffering from multiple sclerosis (MS)
Investigation of the validity of the BESTest with Tinetti test, and laboratory tests of force plate and motion camera and evaluation the effect of mental practice on the balance and walking in patients with MS.
Design
A double-blind, randomized clinical trial with community-based and pragmatic control group and parallel group design
Settings and conduct
Twenty-two MS patients are randomly assigned into two experimental and control groups after completing the consent form and gathering data. All patients in both groups are evaluated in 3 stages.1) The before the intervention, 2)after the intervention, 3) two weeks after the last intervention session. Everyone receives common practice for 3 sessions per week for 6 weeks. Also, the interventions group receives mental practice for 20 minutes in addition to the usual exercises.
The method of the second phase (evaluation the validity of BESTest):
17 MS patients and 17 healthy people will be evaluated using Tinetti test, BESTest, force plate (static Balance) and motion camera (Dynamic Balance).
Participants/Inclusion and exclusion criteria
Inclusion criterion: MS diagnosis by specialist physician; EDSS = 1-5; People aged 18-18; Satisfaction to participate in the research. ٍExclusion criteria: Pregnancy; mental problems; fractures, presence of implants in the body, a history of attack and recurrence within the last 2 months.
Intervention groups
Intervention group includes 11 MS patients who receive 20 minutes of mental training in addition to common practice. Control group includes 11 MS patients who receive the only common practice of occupational therapy.
Main outcome variables
Walking; Independence in activity of daily living ; balance.
General information
Reason for update
Acronym
MS
IRCT registration information
IRCT registration number:IRCT20181107041588N1
Registration date:2019-04-13, 1398/01/24
Registration timing:retrospective
Last update:2019-04-13, 1398/01/24
Update count:0
Registration date
2019-04-13, 1398/01/24
Registrant information
Name
Fatemeh Hoseinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3256 3616
Email address
h.hoseinpour_ot@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of mental exercise and routine occupational therapy on balance and walking performance among patients suffering from multiple sclerosis (MS)
Public title
Balance in MS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of MS by an specialist physician
People with mild to moderate disability scale (EDSS = 1-5)
Age range of 18-65 years old
At least 2 years after the onset of MS
Voluntarily participation in the research
َAbility to perform exercises
MMSE scores above 23 to ensure required cognitive function
Exclusion criteria:
Pregnancy
having mental problems as well as fractures and the presence of implants in the body (according to patient records)
having a history of attack and recurrence within the last 2 months (according to patient records)
history of other neurological diseases (according to patient records)
previous history of the epilepsy, tumors, osteoporosis, diabetes, etc. according to the physician diagnosis
corticosteroid medication till 28 days before the evaluation
visual and/or auditory problems that may interfere with the tests
Failure to have mental retardation
previous history of psychiatric illness that interferes with the examination process
previous history of addiction and using psychoactive substances
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Via simple randomization method using number box, the subjects will be individually assigned to two groups. Using random allocation rule (RAR), a bog box is provided for all samples, i. e., each subject is allocated a code number between one to last number, after final sample allocation. All codes are placed in a non-transparent envelope, and then, some numbers are transferred blindly from the first envelope to second, until half of the code numbers are been transferred. Then, each envelope will be allocated to experimental and control groups via dropping coin. Finally, the numbers in each envelope are matched to the name of the subjects and will refer to receiving relevant interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
1- The researcher encodes patients after compliance with the entry criteria (each patient receives a code)
2. the assessor is Blind to the subjects assignment to the intervention group. He/she Assesses patients, refer them to rehabilitation services.
3. The subject's blindness to the intervention group: The patient receives special care for the group by providing a card containing the code without informing or communicating with other patients.
4. Blindness of the occupational therapist to the subjects assignment to the intervention group. The therapist provides occupational therapy services according to the protocol to each patient-code.
5. Patients with code belonging to the experimental group will refer to the special training site and receive the relevant services.
6. Blindness of the information analyzer on the subjects’ assignment to the intervention group. Data will be evaluated and compared in three steps (before and after intervention and follow up). Then, two groups with different codes (blind to assigning code to the intervention group) are also compared.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of The University of Social welfare and Rehabilitation Sciences
Street address
Koodak Yar Street, Daneshjoo Boulevard,Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۷۱
Approval date
2018-03-11, 1396/12/20
Ethics committee reference number
IR.USWR.REC.1396.300
Health conditions studied
1
Description of health condition studied
patients whit MS
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
walking function
Timepoint
Before receiving interventions, after the last intervention session and two weeks after the intervention
Method of measurement
Using the questionnaire and patient records
Secondary outcomes
1
Description
Independence in activities of daily living performances (ADL)
Timepoint
Pretest, post test, two weeks follow-up
Method of measurement
Barthel Index
Intervention groups
1
Description
Intervention group 1: 11 patients with MS are selected as the intervention group. These subjects will receive mental practice for 20 minutes, in addition to the common occupational therapy exercises. The intervention will be conducted for 3 sessions per week and for 6 weeks. Individuals are evaluated in three times (1) before interventions (2) after interventions (3) 2 weeks after the last session of the intervention.
Category
Rehabilitation
2
Description
Control group 1: 11 patients with MS will be assigned as control group 1 and will receive common occupational therapy exercises for 3 45-minute sessions per week for 6 weeks. The participants will be evaluated in three times (1) before intervention (2) after intervention (3) 2 weeks after the last session of the intervention.