Protocol summary

Summary
In this study, therapeutic effects of an anti-gravity locomotor training on central nervous system structure and function, neuromuscular properties and gait in children with cerebral palsy will be studied. 100 children with cerebral palsy will be referred to neural engineering and rehabilitation center of Noorafshar hospital from rehabilitation and medical centers. 4-14 years old hemiplegic patients with spasticity in lower extremities and also with the ability of following commands who are diagnosed by pediatric neurologists will be randomly separated to study and control groups. The study group will be trained on the anti-gravity treadmill and the control group will receive over-ground walking training by an expert occupational therapist. Each group will receive up to 1 hour of training for 3 days/week for 2 months. The anti-gravity treadmill will facilitate treadmill walking with reduced lower extremity weight bearing (up to %80), which can help patients walk voluntary and actively on the treadmill. It is expected that this systematic, intensive training result in structural changes (neuroplasticity) in central nervous system, so that the nerve conduction will be facilitated and improved in neural pathways. It is expected that this systematic, intensive training result in structural changes (neuroplasticity) in central nervous system, so that the nerve conduction will be facilitated and improved in neural pathways. As a result of this neuroplasticity, the treatment effects will be long lasting and improve the children’s quality of life. In addition to evaluating the clinical changes, brain structural changes, activity level of the descending neural pathways including corticospinal tracts, neuromuscular properties, balance, and the lower limbs movement ability of the children will be quantified.

General information

Acronym
CP-PGT
IRCT registration information
IRCT registration number: IRCT2015121625568N1
Registration date: 2016-09-06, 1395/06/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-06, 1395/06/16
Registrant information
Name
Seyed Mohammad Mehdi Mirbagheri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6405 3252
Email address
mehdi@northwestern.edu
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Siences Red Crescent of Iran Clinical Neural Engineering Research Center in Noor-Afshar Hospital
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Motor Learning Induced by an Anti-gravity Locomotor Training in Children With Cerebral Palsy
Public title
Therapeutic Effects of an Anti-gravity Locomotor Training on Central Nervous system structure and function, Neuromuscular Properties and Gait in Children with Cerebral Palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: hemiplegic patients diagnosed by a pediatric neurologist; Spasticity in lower extremities (MAS Score >1); ability to attend training/test sessions; ability of following commands; absence of severe mental retardation; absence epilepsy, chromosomal anomaly, or genetic syndrome;. absence of severe brain structural anomaly
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
TUMS, PoorSina st., Ghods st. ,Enghelab st., tehran, Iran
City
Tehran
Postal code
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
IR.TUMS.REC.1395.2441

Health conditions studied

1

Description of health condition studied
Hemiplegic Cerebral Palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy

Primary outcomes

1

Description
Fractional Anisotropy
Timepoint
Four times: once a month
Method of measurement
MRI Acquisition; Post Analysis

2

Description
Mean Diffusivity
Timepoint
Four times: once a month
Method of measurement
MRI Acquisition; Post Analysis

3

Description
Berg Balance Scale
Timepoint
Four times: once a month
Method of measurement
Clinical evaluations

4

Description
Center Of Pressure Distance
Timepoint
Four times: once a month
Method of measurement
Gait Analaysis

5

Description
Stride Velocity
Timepoint
Four times: once a month
Method of measurement
Gait Analaysis

6

Description
Maximum Velocity Conraction
Timepoint
Four times: once a month
Method of measurement
Isokinetic

7

Description
cranial magnetic stimulation threshold
Timepoint
Four times: once a month
Method of measurement
TMS

8

Description
H-Reflex
Timepoint
Four times: once a month
Method of measurement
EMG Device

9

Description
Tissue Elasticity
Timepoint
Four times: once a month
Method of measurement
Sonoelastography

10

Description
Velocity and Endorance
Timepoint
four times: once a month
Method of measurement
clinical evaluations

Secondary outcomes

empty

Intervention groups

1

Description
AlterG group will receive 3 days/week for 8 weeks, with up to 1 hour of training per session.In each session, the training started with no body weight support and with a minimum speed.Then, the body weight support gradually increased and the speed increased as needed based on the subject’s ability and the desecration of the trainer.
Category
Rehabilitation

2

Description
The control group will receive over ground walking training by an expert occupational therapist 3 days/week for 8 weeks, with up to 1 hour of training per session.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Noorafshar hospital
Full name of responsible person
Maryam Shahrokhnia
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Children's Medical center
Full name of responsible person
Parmida Moradi Birgani
Street address
City
Tehan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
TUMS
Full name of responsible person
Seyed Mohamad Mehdi Mirbagheri
Street address
TUMS, Pour Sina St., Ghods St., Enqelab Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
TUMS
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
TUMS
Full name of responsible person
Parmida Moradii Birgani
Position
PhD student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Pour Sina St., Ghods St., Enqelab Sq.
City
Tehran
Postal code
1417613151
Phone
+98 21 6646 6383
Fax
Email
parmida.mb@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
TUMS
Full name of responsible person
Seyed Mohamad Mehdi Mirbagheri
Position
Post Doc
Other areas of specialty/work
Street address
TUMS, Pour Sina St., Ghods St., Enqelab Sq.
City
Tehran
Postal code
1417613151
Phone
+98 21 6646 6383
Fax
Email
mehdi@northwestern.edu
Web page address

Person responsible for updating data

Contact
Name of organization / entity
TUMS
Full name of responsible person
Shokoofeh Parvin
Position
M.Sc.
Other areas of specialty/work
Street address
TUMS, Pour Sina St., Ghods St., Enqelab Sq.
City
Tehran
Postal code
1417613151
Phone
+98 21 6646 6383
Fax
Email
sh-parvin@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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