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Effects of Different Time Period of Standing Frame on Spasticity and Gait in Children With Spastic Cerebral Palsy.

Primary Purpose

Spastic Cerebral Palsy, Spastic Gait

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional physical therapy
standing frame.
Sponsored by
Shifa Tameer-e-Millat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Cerebral Palsy, Modified Ashworth scale, 6 minute walk test

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Spastic CP with age limit between 4-14 years.
  • Both genders.
  • At least 40° knee flexion.
  • Sitting achieved on ground.
  • mass at least with grade 3.

Exclusion Criteria:

  • Children with knee flexor contractures > 60°.
  • Hip flexor contractures > 60°.
  • Planter flexor contractures > 30°.
  • Severe mental retardation.

Sites / Locations

  • Shifa tameer e millat universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

group a

group b

group c

group d

Arm Description

15 minute on standing frame .

30 minute on standing frame .

45 minute on standing frame.

60 minute on standing frame.

Outcomes

Primary Outcome Measures

modified ashworth scale.
mas used to assess spasticity of lower limb muscles bilaterally i.e. hip flexors, hip extensors hip abductors hip adductors , ankle dorsiflexors and ankle planter flexiors.
6 minute walk test.
6 minute walk test to assess gait. walk for 6 minute . children can take rest but time will not be stopped. measure distance in meters.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2021
Last Updated
November 9, 2021
Sponsor
Shifa Tameer-e-Millat University
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1. Study Identification

Unique Protocol Identification Number
NCT05113433
Brief Title
Effects of Different Time Period of Standing Frame on Spasticity and Gait in Children With Spastic Cerebral Palsy.
Official Title
Effects of Different Time Period of Standing Frame on Spasticity and Gait in Children With Spastic Cerebral Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Anticipated)
Primary Completion Date
December 2, 2021 (Anticipated)
Study Completion Date
December 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Tameer-e-Millat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cerebral palsy is a neurological disorder with abnormalities in muscle tone, movement disorders and motor incapability. It attributes to harm to the growing brain. Cerebral approach including brain and its palsy referred to weakness and problems while using the muscles. It is characterized by way of the incapability to normally control motor features, and it has. the capacity to have an impact on the general improvement of a child with the aid of affecting the child's capability to explore, talk, learn, and grow to be independent. Spastic CP is the most common type among children and debts for almost 77% among all instances. It is the major problem in CP child making movement difficult or even impossible.
Detailed Description
Cerebral palsy itself is not considered as a. progressive disease rather it is a medical. expression that may trade with time as the brain grows. It is attributed as the physical disability that is commonly present in children whose diagnosis can be made. before 6 months. Cerebral palsy is mostly considered as the commonplace physical incapacity among children .and it impacts almost 2 -2.5/1000 children born in United State of America. Population based information displays that the percentage of intense cases of CP is very high among low and middle earned international countries. Children with CP born in low offerings .Children with cerebral palsy mostly have spastic syndrome in common. Prolong sustain stretch is an effective treatment traditionally used to reduce spasticity. We can use the effect of frame and gravity or automatically, the usage of device or splints to carry out sustain stretch manually. A standing frame is a mechanical (vintage) or mechatronic (new) equipment, that has as principal aim to accurate the incapacity of certain individual for assuming the body's vertical position. The type of cerebral palsy relies upon on the kind of movement disorders in children affecting the body parts. The classification of CP which is topographically involves: Quadriplegic Hemiplegic Diplegic Monoplegic And triplegic cerebral palsy Clinical history may help an early diagnosis which involves the use of neuroimaging, standardized tests with neurological and motor aspects which indicates congruent ordinary findings indicating cerebral palsy. The importance of spark off referral need to be recognized by the clinicians to be specifically diagnostic before the start of intervention so that treatment can be optimized for the prevention of secondary complications. Types of CP contributes in the early diagnosis with presence of epilepsy, a larger degree of motor incapacity, and cerebral abnormalities in ultrasonography. There is no association between gestational and diagnostic age. Neuroimaging is presently endorsed as a general assessment. MRI showing excessive abnormality in white matter had a strong association with CP as compared to general movements present .MRI with respect to its diagnostic value is not as better as consecutive ultrasonography, the reason behind this fact is that MRI is much demanding, but MRI in daily routine is not going to turn out as a standard exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy, Spastic Gait
Keywords
Cerebral Palsy, Modified Ashworth scale, 6 minute walk test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group a
Arm Type
Experimental
Arm Description
15 minute on standing frame .
Arm Title
group b
Arm Type
Experimental
Arm Description
30 minute on standing frame .
Arm Title
group c
Arm Type
Experimental
Arm Description
45 minute on standing frame.
Arm Title
group d
Arm Type
Experimental
Arm Description
60 minute on standing frame.
Intervention Type
Other
Intervention Name(s)
conventional physical therapy
Intervention Description
muscle strengthening i.e. isometrics of lower limb muscles. 5 sets/rep and 2 sets/ session. stretching of lower limb muscles . 5sets/rep and 2 sets/session.
Intervention Type
Other
Intervention Name(s)
standing frame.
Intervention Description
muscle strengthening i.e. isometrics of lower limb muscles. 5 sets/rep and 2 sets/ session. stretching of lower limb muscles . 5sets/rep and 2 sets/session. sanding on standing frame for different time period according to group with upper limb activities lie box and blocks , cones and theraputty .
Primary Outcome Measure Information:
Title
modified ashworth scale.
Description
mas used to assess spasticity of lower limb muscles bilaterally i.e. hip flexors, hip extensors hip abductors hip adductors , ankle dorsiflexors and ankle planter flexiors.
Time Frame
4 weeks
Title
6 minute walk test.
Description
6 minute walk test to assess gait. walk for 6 minute . children can take rest but time will not be stopped. measure distance in meters.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spastic CP with age limit between 4-14 years. Both genders. At least 40° knee flexion. Sitting achieved on ground. mass at least with grade 3. Exclusion Criteria: Children with knee flexor contractures > 60°. Hip flexor contractures > 60°. Planter flexor contractures > 30°. Severe mental retardation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shafaq Altaf, Phd*
Phone
03435020507
Email
shafaq_dpt.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Nouman Khan, MS-OMPT
Phone
03339378324
Email
nouman_drs.ahs@stmu.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shafaq Altaf, Phd*
Organizational Affiliation
Shifa tameer e millat university Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shifa tameer e millat university
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shafaq Altaf, Phd*
Phone
03435020507
Email
shafaq_dpt.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Nouman Khan, Ms- OMPT
Phone
03339378324
Email
nouman_drs.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Anum Shehzadi, MSNMPT*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28071965
Citation
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Citation
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Effects of Different Time Period of Standing Frame on Spasticity and Gait in Children With Spastic Cerebral Palsy.

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