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Effect of Pelvic Control Exercises in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pelvic and trunk control exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

45 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Patient's age will range from 45 - 60 years. Muscle tone grade will range from 1 to 1+ according to modified Ashworth scale. Duration of illness will range from 6 to 18 months after stroke onset. Ability of the patient to stand without assistive devices. Exclusion Criteria: • Other neurological or musculoskeletal disorders that might affect pelvic alignment such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures, contractures of fixed deformity or leg length discrepancy. Severe chronic back and/or knee pain that might affected standing posture. Recurrent stroke Shoulder or upper limb injury that might affect the recovery. Perceptual or cognitive dysfunctions. BMI > 30

Sites / Locations

  • Faculty of physical therapy labs at Cairo UniversityRecruiting
  • Faculty of physical therapy labs at Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Pelvic and trunk control exercises

Traditional physical therapy

Arm Description

Twenty Egyptian male stroke patients will receive 40 minutes of pelvic and trunk control exercises for six weeks after a 30 minutes of traditional physical therapy program.

Twenty Egyptian male stroke patients will receive 30 minutes of sham traditional physical therapy program for six weeks.

Outcomes

Primary Outcome Measures

Biodex System 3 Pro Isokinetic
Changes in peak muscle torque of upper limb muscles from baseline to four weeks after the beginning of intervention

Secondary Outcome Measures

Fugl-Meyer Assessment for upper extremity
Changes in upper limb function from baseline to four weeks after the beginning of intervention
Box and block test
Changes in gross hand function from baseline to four weeks after the beginning of intervention
Hand grip dynamometer
. Changes in hand grip strength from baseline to four weeks after the beginning of intervention

Full Information

First Posted
September 28, 2023
Last Updated
September 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06067724
Brief Title
Effect of Pelvic Control Exercises in Stroke
Official Title
Effect of Pelvic and Trunk Control Exercises on Function Outcome of Affected Upper Extremity in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2023 (Actual)
Primary Completion Date
October 20, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the study is to investigate the combined effect of pelvic and trunk control exercises on muscle performance of affected upper extremity in stroke patients.
Detailed Description
The study conducted on forty stroke patients. They assessed by Biodex System 3 Pro Isokinetic, Modified Ashworth Scale(MAS), Fugel Meyer Assessment scale (FMAS), Box and block test and hand grip dynamometer. Patients divided into control group and study group. The control group treated by a traditional physical therapy program.The study group treated by the traditional physical therap program in addition to pelvic and trunk control exercises for 40 min.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic and trunk control exercises
Arm Type
Active Comparator
Arm Description
Twenty Egyptian male stroke patients will receive 40 minutes of pelvic and trunk control exercises for six weeks after a 30 minutes of traditional physical therapy program.
Arm Title
Traditional physical therapy
Arm Type
Sham Comparator
Arm Description
Twenty Egyptian male stroke patients will receive 30 minutes of sham traditional physical therapy program for six weeks.
Intervention Type
Other
Intervention Name(s)
Pelvic and trunk control exercises
Intervention Description
Patients in this group will be treated by the traditional physical therapy program in addition to a 18 sessions of pelvic control exercises for 40 min included pelvic tilting exercises and pelvic stabilization exercises from different positions. Pelvic tilting exercises included anterior, posterior and lateral pelvic tilting. Pelvic stabilization exercises include bridging, planking, clamshell and quadribed exercises. In addition to trunk control exercise which consist of lifting the pelvis with crock-lying, unilateral pelvic bridge, upper trunk flexion rotation, and lower trunk flexion rotation, flexion extension of the lower trunk, upper trunk lateral flexion, lower trunk lateral flexion, upper trunk rotation, lower trunk rotation, forward reach, and lateral reach.
Primary Outcome Measure Information:
Title
Biodex System 3 Pro Isokinetic
Description
Changes in peak muscle torque of upper limb muscles from baseline to four weeks after the beginning of intervention
Time Frame
Six weeks after the beginning of the intervention
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment for upper extremity
Description
Changes in upper limb function from baseline to four weeks after the beginning of intervention
Time Frame
Six weeks after the beginning of the intervention
Title
Box and block test
Description
Changes in gross hand function from baseline to four weeks after the beginning of intervention
Time Frame
Six weeks after the beginning of the intervention
Title
Hand grip dynamometer
Description
. Changes in hand grip strength from baseline to four weeks after the beginning of intervention
Time Frame
Six weeks after the beginning of the intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient's age will range from 45 - 60 years. Muscle tone grade will range from 1 to 1+ according to modified Ashworth scale. Duration of illness will range from 6 to 18 months after stroke onset. Ability of the patient to stand without assistive devices. Exclusion Criteria: • Other neurological or musculoskeletal disorders that might affect pelvic alignment such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures, contractures of fixed deformity or leg length discrepancy. Severe chronic back and/or knee pain that might affected standing posture. Recurrent stroke Shoulder or upper limb injury that might affect the recovery. Perceptual or cognitive dysfunctions. BMI > 30
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rowida Abdelgleel, Assistant lecturer
Phone
01152322678
Email
rowidaabdelglel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nahed Salem, Professor
Phone
+201224297063
Email
nahedsalem960@gmail.com
Facility Information:
Facility Name
Faculty of physical therapy labs at Cairo University
City
Giza
ZIP/Postal Code
12612
Country
Egypt
Individual Site Status
Recruiting
Facility Name
Faculty of physical therapy labs at Cairo University
City
Giza
ZIP/Postal Code
12612
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rowida Abdelgleel, Assistant lecturer
Phone
01152322677
Email
rowidaabdelglel@gmail.com

12. IPD Sharing Statement

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Effect of Pelvic Control Exercises in Stroke

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