Identifying the effect of kinesiotaping on the plantar arch index among 2-6 years old spastic diplegic children with cerebral palsy
Design
The study clinical trial and not blinded and of 20 patients is randomly will divide into 2 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Candidates cerebral palsy in Sepehr occupational therapy center are divided into2 groups by simple randomization with envelopes. The study is not blind.
The control group will benefit from ordinary rehabilitation exercises to reduce their flat feet deformity, while the intervention group will receive kinesiotaping beside the ordinary exercises. Both groups will be evaluated before and after the study( after 4 months).
Main outcome variables
plantar arch index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190214042710N1
Registration date:2021-05-15, 1400/02/25
Registration timing:registered_while_recruiting
Last update:2021-05-15, 1400/02/25
Update count:0
Registration date
2021-05-15, 1400/02/25
Registrant information
Name
Mohammad Karim Golnari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 3234
Email address
mohamad.3602@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of kinesiotaping on the plantar arch index among 2-6 years old spastic diplegic children with cerebral palsy
Public title
The effect of kinesiotaping on the plantar arch index
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dipplegia cerebral palsy
Age 2 to 6 years
Exclusion criteria:
Dissatisfaction
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 2 groups A and B . In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Occupational therapy department, School of paramedical sciences, Parvin Etesami Blvd
City
Zanjan
Province
Zanjan
Postal code
4515786349
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.ZUMS.REC.1396.312
Health conditions studied
1
Description of health condition studied
cerebral palsy
ICD-10 code
G80.1
ICD-10 code description
Spastic diplegic cerebral palsy
Primary outcomes
1
Description
plantar arch index
Timepoint
at the start and the end of the study( after 4 months)
Method of measurement
Staheli method
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Common plantar flattening exercises were used. Common exercises performed in the control group include: 1. Walking with the outer edge of the legs, 2. Walking in a T-shape so that the front leg rotates inwards horizontally when walking, 3. The person sits and places his or her legs with the knee in full extension. And at the same time stretch the gastrocnemius muscle by bringing his hands to the toe, 4. standing with the inverted foot, 5. walking on the heel, 6. standing on the wall to stretch the muscles of the back leg, 7. Walking with the heel cycle, the outer edge and getting up on the toe, 8. Getting up on the toe with the supine foot, 9. Drawing a circle with the toes of both feet while sitting, 10. The person is standing on the stairs with his toes on Stand out from the edge of the stairs, at which point the person tries to bend their fingers. Exercises are done for 4 months.
Category
Treatment - Other
2
Description
Intervention group: In addition to the mentioned exercises, kinesiotyping (Stretching exercises for shortened muscles and strengthening exercises for weak muscles) method was used. Stretching exercises included exercises to stretch the short fibularis muscles, long fibularis gastrocnemius, and strengthening exercises exercises included strengthening the posterior and anterior tibialis muscles, the soleus muscles, and the flexor muscles of the toes.Exercises are done for 4 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sepehr occupational therapy center
Full name of responsible person
Mohammad Karim Golnari
Street address
No. 20, Alborz Bldg, Ghaleh Ave, Saadi St
City
Zanjan
Province
Zanjan
Postal code
4513954215
Phone
+98 24 3332 6176
Email
mohamad.3602@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45154
Phone
+98 24 3342 0651
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?