Design, construction and evaluation of the effectiveness of hip flexion orthosis on pain and quality of life in patients with MS
Design
The trial has an intervention group and is performed on 25 people.
Settings and conduct
First, Orthosis Assist Flexion Hip is designed and manufactured based on similar studies and cases. After confirming the design of the orthosis, an evaluation is performed. The participants is referred to the hip flexion (Hip Flexion Assist Orthosis) with the diagnosis of MS according to the expert's opinion. Muscle strength and range of motion of joints, pain and quality of life are assessed before orthosis use. People will be told how to wear, remove, and use orthosis, and they will be asked to use orthosis for a month during walking and daily activities. After a month, the pain and quality of life are evaluated again. During this period, patients are followed up by telephone.
Participants/Inclusion and exclusion criteria
Inclusion criteria: MS in the first stage of recurrence and recovery and expanded disability scale from 4 to 6; with the ability to walk independently, with the highest grade of spasticity 2 based on Ashworth scale;
Conditions of absence: history of cardiorespiratory disease; flexion contracture fixed in one of the hip or knee or ankle joints; cognitive disorders
Intervention groups
The orthosis is given to the patient with MS. The use of orthoses is explained to people and they are asked to use orthoses for a month during walking and daily activities.
After a month, the pain and quality of life are evaluated again.
Main outcome variables
Design, construction and evaluation of the effectiveness of hip flexion orthosis on pain and quality of life in patients with MS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210522051361N1
Registration date:2021-09-23, 1400/07/01
Registration timing:prospective
Last update:2021-09-23, 1400/07/01
Update count:0
Registration date
2021-09-23, 1400/07/01
Registrant information
Name
Erfan Mobarak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 6729
Email address
mobarak.erfan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-09, 1400/09/18
Expected recruitment end date
2022-03-09, 1400/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of hip flexion-assisted orthosis on reducing pain and improving the quality of life in patientswith MS
Public title
Evaluation of the effectiveness of hip flexion-assisted orthosis on reducing pain and improving the quality of life in patientswith MS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
MS in the first stage of recurrence and recovery and extended disability scale from 4 to 6; with the ability to
Having the ability to walk independently with the maximum grade of spasticity 2, based on Ashworth scale
Exclusion criteria:
Positive history of cardiorespiratory disease
Fixed Flexion contracture of hip knee or ankle joint
Cognitive disorders
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research, Iran University of Medical Sciences
Street address
Iran university of medical science
City
Tehran
Province
Tehran
Postal code
Approval date
2021-07-27, 1400/05/05
Ethics committee reference number
IR.IUMS.REC1400.404
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
Check for pain
Timepoint
30 day
Method of measurement
Pain Visual Analogue Scales
2
Description
Quality of life specific to MS patients
Timepoint
30 Day
Method of measurement
multiple sclerosis quality of life questionnaire
3
Description
General quality of life
Timepoint
30 day
Method of measurement
short form 36 health survey questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants are referred to the hip flexion assist orthosis with the diagnosis of MS according to the expert's opinion. Muscle strength and range of motion of joints, pain and quality of life are assessed before orthosis use. People are explained how to wear, remove and use orthoses and are asked to use orthoses for a month during walking and daily activities. After a month, the pain and quality of life are assessed again. During this time, patients are followed up by telephone.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Bijan Forough
Street address
Firoozgar Hospital, Beh Afarin Ave
City
Tehran
Province
Tehran
Postal code
15937 48711
Phone
+98 21 2244 6729
Email
mobarak.erfan@gmail.com
2
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mohaddese Azadvari
Street address
Sina Hospital, Amir Kabir Ave
City
Tehran
Province
Tehran
Postal code
11367 46911
Phone
+98 21 2244 6729
Email
mobarak.erfan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bijan Forough
Street address
Beh Afarin Ave, Firoozgar Hospital
City
Tehran
Province
Tehran
Postal code
15937 48711
Phone
+98 21 2244 6729
Email
mobarak.erfan@gmail.com
Grant name
Neuromusculoskeletal Research Center
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?