To compare the immediate effects of ankle-foot orthosis and Dictus-band on the gait and balance of people with multiple sclerosis
Design
This is a crossover clinical trial. The sample size was determined based on the previous similar studies and set at 15 participants. The gait of all participants (in a single group) were tested in three conditions: with an ankle-foot orthosis, with dictus-band, and barefoot.
Settings and conduct
There was a convenience sampling method. Participants were recruited from outpatient clinics of Alzahra hospital, Isfahan, Iran. Blinding of participants was not possible as they could see what they worn. Automated measurements were used to prevent assessment bias in the balance and gait testing.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the expanded Disability Status Scale (EDSS) between 3 to 6, walking ability without assistance of a device or person.
Exclusion criteria: history of the relapse in the last three months, inability to give an informed consent due to cognitive problems, musculoskeletal conditions that affect the gait, curdio-pulmonary problems that could prevent the testing, and having severe depression (Beck score>40).
Intervention groups
Intervention 1: a static ankle-foot orthosis that restricts plantar flexion. Intervention 2: a soft dynamic orthosis is called Dictus-Band that assists dorsi flexion at the ankle. Control: barefoot (without orthosis).
Main outcome variables
Postural stability; speed in 10 meter walking test; Forward reach test; "get up and go" test time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021034N8
Registration date:2020-03-31, 1399/01/12
Registration timing:retrospective
Last update:2020-03-31, 1399/01/12
Update count:0
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Ebrahim Sadeghi-Demneh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5235
Email address
sadeghi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-09, 1395/03/20
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
2017-04-30, 1396/02/10
Actual recruitment end date
2017-08-21, 1396/05/30
Trial completion date
2017-08-21, 1396/05/30
Scientific title
The immediate effects of using an ankle-foot orhosis and a Dictus-band on the the gait and balance of people with Multiple Sclerosis
Public title
Effects of othoses on the gait of people with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The Expanded Disability Status Scale (EDSS) between 3 to 6
Participants could walk without assistance of a device or person
Exclusion criteria:
People with a history of relapse in the last three month
People with cognitive problem who could not give an informed consent
Musculoskeletal conditions which affect the gait
People with severe cardio-pulmunary problems which could prevent the testing
People with severe depression (Beck score>40)
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Actual sample size reached:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
IR.MUI.REC.1394.3.979
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
Postural stability
Timepoint
All intervention was allocated in a straight forward session and outcomes were measured 10 minutes after receiving trial conditions.
Method of measurement
Participants were asked to stand quiet on the measurement equipment (force-plate) whilst put the feet together and keep the arms relaxed beside the body. The center of pressure was recorded during 60 second of standing.
2
Description
speed in 10 meter walking test
Timepoint
All intervention was allocated in a straight forward session and outcomes were measured 10 minutes after receiving trial conditions.
Method of measurement
Participants were asked to walk in a 10 meter path then time recorded with a stopwatch and speed of walking was calculated.
3
Description
Forward reach test
Timepoint
All intervention was allocated in a straight forward session and outcomes were measured 10 minutes after receiving trial conditions.
Method of measurement
Participants stood with feet together and raised the arm at their shoulder level then leaning forward as much as could with heels in contact with the ground. The anterior displacement of the hand was measured using a yardstick or tape.
4
Description
"get up and go" test time
Timepoint
All intervention was allocated in a straight forward session and outcomes were measured 10 minutes after receiving trial conditions.
Method of measurement
Participants sat on a chair to start the test. They get up with a "go" signal and walk until reach a line at 3 meters distance from the chair then turned and walk back to the chair and sit on it. The time was recorded using a stopwatch.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention: ankle-foot orthosis, was a custom-made orthosis. this was a thermoplastic polypropylene orthosis. The footplate of orthosis covered with an anti-slipping rubber and was used without shoes. After fitting the orthosis, participant walk in a five-meter walkway and a motion analyzer system records their movements.
Category
Rehabilitation
2
Description
Second intervention: Dynamic orthosis (dictus-band); consisted of a leg band, a foot band and a connecting rubber band. This orthosis was fitted based on the participant's size. After fitting the orthosis, participant walk in a five-meter walkway and a motion analyzer system records their movements.
Category
Rehabilitation
3
Description
Control: barefoot (without orthosis); participants walk in a five-meter walkway and a motion analyzer system records their movements.