The efficiency of articulated ankle-foot orthosis with first and second rockers mechanism and rocker sole shoe on walking biomechanics in patients with hemiplegic stroke: Randomized Clinical Trial
Effect of an AFO with plantarflexion resistance (for improving first and second rockers) and rocker sole shoe (for improving the third rocker) on gait parameters of stroke patients.
Design
The present study is a randomized, parallel-group controlled trial. The study group (n=10) will receive an articulated AFO with resistance to plantarflexion (AFO-PR) with 2 shoes types (standard shoe and rocker shoe), and the control group (n=10) will receive a conventional articulated AFO with plantarflexion stop (AFO-PS) with 2 shoes types (like study group). Blinding of patients or therapists was not possible in all articles because of the nature of the intervention
Settings and conduct
1. University of Social Welfare and Rehabilitation Science, Iran, Tehran
2. Dr. jawad Mowafaghian Research Center for Intelligent NeuroRehabilitation Technologies, Sharif University of Technology
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Stroke patients should have plantarflexors spasticity at least 2 according to the modified Ashworth scale
-A minimum of 6 months post stroke
Exclusion criteria:
A fixed contraction in the ankle hip and knee joints
Patients with knee hyperflexion
Very poor balance based on TUG test
Intervention groups
Study group: articulated AFO with plantarflexion resistance
control group: conventional articulated AFO with plantarflexion stop
Main outcome variables
Walking parameters including:
1.Temporal-spatial parameters (walking speed, step length, stride length, cadence)
2. Walking Kinematic (sagittal joints angles of ankle, knee and hip, and pelvic 3-dimensional angles in pelvis and thorax)
3. Walking Kinetic (sagittal joints moments of ankle, knee and hip, anterior-posterior ground reaction force).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190625044003N1
Registration date:2019-09-12, 1398/06/21
Registration timing:registered_while_recruiting
Last update:2019-09-12, 1398/06/21
Update count:0
Registration date
2019-09-12, 1398/06/21
Registrant information
Name
Aliyeh Daryabor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0010
Email address
r_daryabor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficiency of articulated ankle-foot orthosis with first and second rockers mechanism and rocker sole shoe on walking biomechanics in patients with hemiplegic stroke: Randomized Clinical Trial
Public title
The efficiency of articulated ankle-foot orthosis and rocker sole shoe on walking biomechanics in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 to 68
Stroke patients should have plantarflexors spasticity at least 2 according to the modified Ashworth scale (MAS)
A minimum of 6 months poststroke
No involvement in the contralateral limb
Able to walk independently
Patients should have the passive ability to dorsiflex ankle joint
Exclusion criteria:
The presence of hammered toes,
Fixed contraction in the ankle, hip and knee joints,
Having a history of cardiovascular and pulmonary disease
Patients with knee hyperflexion
Very poor balance based on TUG test
Age
From 40 years old to 68 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Since the sampling method in the present study is consecutive. It means that researcher gets present at the patients' referral site (Dr. Jawad Mowafaghian Research Center for Intelligent NeuroRehabilitation Technologies) from the beginning of the study, and patients who are eligible to participate in the study are identified and then, invited to participate in the study. Therefore, randomization is occurred consecutively. It should be noted that only one rehabilitation center is sampled in this study. In this study, simple randomization method is used and randomization unit is individual. In this way, participants with the odd number assigned to them (By order of referral) are included in the intervention group, and participants with the even number assigned to them are included in the control group. The allocation concealment is that Participants are unaware of the allocation of groups (intervention and control group).
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants (patients) are unaware of the allocation of groups (intervention group and control group). That is, participants are unaware of which group, intervention group, and which group is the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Science
In this study, after fabrication of orthoses for patients, the subjects use the made orthosis for adapting in daily living for 2 weeks. Then, patients refer to gait biomechanics laboratory, and gait parameters are measure in two condition, without orthosis and with orthosis
Method of measurement
Three-dimensional movement capture system (vicon)
2
Description
Walking Kinematic (sagittal joints angles of ankle, knee and hip, and pelvic 3-dimensional angles in pelvis and thorax)
Timepoint
In this study, after fabrication of orthoses for patients, the subjects use the made orthosis for adapting in daily living for 2 weeks. Then, patients refer to gait biomechanics laboratory, and walking Kinematic are measure in two condition, without orthosis and with orthosis
Method of measurement
Three-dimensional movement capture system (vicon)
3
Description
Walking Kinetic (sagittal joints moments of ankle, knee and hip, anterior-posterior ground reaction force).
Timepoint
In this study, after fabrication of orthoses for patients, the subjects use the made orthosis for adapting in daily living for 2 weeks. Then, patients refer to gait biomechanics laboratory, and walking Kinetics are measure in two condition, without orthosis and with orthosis.
Method of measurement
Kistler forceplate
Secondary outcomes
1
Description
Fatigue during walking with orthoses
Timepoint
In this study, after fabrication of orthoses for patients, the subjects use the made orthosis for adapting in daily living for 2 weeks. Then, patients refer to gait biomechanics laboratory, and fatigue variable are measure in two condition, without orthosis and with orthosis by the questionnaire.
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: ankle foot orthosis (AFO) with plantar flexion resistance and 2 kind of shoes (standard shoe and rocker shoe)
Category
Rehabilitation
2
Description
Control group: Intervention group: ankle foot orthosis (AFO) with plantar flexion resistance and 2 kind of shoes (standard shoe and rocker shoe)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Djawad Mowafaghian Research Center for Intelligent NeuroRehabilitation Technologies
Full name of responsible person
Dr. Farzam Farahman and Dr. Saeid Behzadipour
Street address
Tehran, Enghelan Street, Khark Avenue, No 11
City
tehran
Province
Tehran
Postal code
13813-11339
Phone
+98 21 6671 6100
Fax
+98 21 6671 6101
Email
contact@sharifrehab.com
Web page address
http://gdfgrtas.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Dr. Iman Eftekhari
Street address
No 3, fifth alley, above the junction of Jalal Al Ahmad, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8216 1159
Fax
Email
interdisciplinary@insf.org
Web page address
http://www.insf.org/
Grant name
Grant code / Reference number
95849762
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences