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Alexander Technique, Routine Physical Therapy, Balance, Posture, Functional Mobility , Chronic, Hemorrhagic, Stroke

Primary Purpose

Chronic Hemorrhagic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Alexander Technique + Routine Physical Therapy
Routine Physical Therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hemorrhagic Stroke focused on measuring Cerebrovascular Accident

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic Hemorrhagic Hemiplegic Stroke.
  • Age40-60Yrs.
  • Both genders.
  • Intact cognition by MMSE.
  • Muscle tone assessment by Ashworth scale.
  • Right or left side.
  • 6th month onset. Exclusion Criteria: -
  • Dizziness.
  • Vertigo.
  • Cerebellum damage.
  • Hearing impairment.
  • Vision impairment

Sites / Locations

  • NACERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alexander Technique + Routine Physical Therapy

Control Group

Arm Description

Routine Physical Therapy+Alexander Technique Verbal Instructions in Trunk stabilising exercises. The time duration will be 15 minutes. Verbal instructions in Stance Phase Time duration 15 minutes.Ankle Strategy. 40 minutes with rest of 5 minutes after 10 minutes. Lessons would be two days a week for 16 weeks.

Routine Physical Therapy duration: two days a week for 16 weeks. Trunk stabilising exercises time duration will be 15 minutes. Stance Phase time duration will be 15 minutes.Ankle Strategy. 40 minutes with rest of 5 minutes after 10 minutes.

Outcomes

Primary Outcome Measures

Berg Balance Scale
The balance will be assessed by the Berg balance scale includes fourteen items .(0-20) specifies high fall risk. (21-50) specifies medium fall risk. (41-56) specifies low fall risk.
Postural Assessment Scale for Stroke
The postural assessment scale for stroke comprised 12 items with a score range of 36. Static and Dynamic PASS rate from 0-3 0 indicates the lowest level of function and 3 indicates the highest level of function.
Time Up and Go Test
Time up and Go test for measuring Distance of Walking within 10-15 seconds .

Secondary Outcome Measures

Full Information

First Posted
February 15, 2022
Last Updated
March 17, 2022
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05255809
Brief Title
Alexander Technique, Routine Physical Therapy, Balance, Posture, Functional Mobility , Chronic, Hemorrhagic, Stroke
Official Title
Effects of Alexander Technique In Addition To Routine Physical Therapy On Balance, Posture And Functional Mobility In Chronic Hemorrhagic Stroke: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Anticipated)
Study Completion Date
October 10, 2022 (Anticipated)

3. Sponsor/Collaborators

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

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
MATERIALS AND METHODS Design: The randomized controlled trial. Setting: Nusrat Abdul Rauf Centre for Enablement, Faisalabad. Sample size:40 in each group. Experimental group: Recieve Alexander Technique with Routine Physical Therapy. Control Group: Recieve Routine Physical Therapy.
Detailed Description
Control Group: Routine Physical Therapy duration: two days a week for 16 weeks. Trunk stabilising exercises time duration will be 15 minutes, Straight static standing.Time duration 15 minutes. Shoulders extend. Threestepsfeet placement.10cm away. Open eye target at 2m away. Arms by side. Ankle Strategy. 40 minutes with rest of 5 minutes after 10 minutes. Raise heel with straight foot & straight head. 20 minutes. Foot raise with straight foot & straight head. 20 minutes. Rest.5 minutes. Experimental Group: Alexander Technique + Routine Physical Therapy duration for two days a week for 16 weeks. Lessons will be 32. Verbal Instructions in Trunk stabilising exercises. Lift the lumber, Head in Centre, fix hands and feet. The time duration will be 15 minutes, Verbal instructions in Stance Phase: Relax-Lighten up-Relax-Pull-up. "Shoulder back", "head up", "tummy in" and "stand up straight". Hip and feet width apart. Straight static standing.Time duration 15 minutes. Shoulders extend. Threestepsfeet placement.10cm away. Open eye target at 2m away. Arms by side. Ankle Strategy. 40 minutes with rest of 5 minutes after 10 minutes. Raise heel with straight foot & straight head. 20 minutes. Foot raise with straight foot & straight head. 20 minutes. Rest.5 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hemorrhagic Stroke
Keywords
Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel
Masking
Outcomes Assessor
Masking Description
Single
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alexander Technique + Routine Physical Therapy
Arm Type
Experimental
Arm Description
Routine Physical Therapy+Alexander Technique Verbal Instructions in Trunk stabilising exercises. The time duration will be 15 minutes. Verbal instructions in Stance Phase Time duration 15 minutes.Ankle Strategy. 40 minutes with rest of 5 minutes after 10 minutes. Lessons would be two days a week for 16 weeks.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Routine Physical Therapy duration: two days a week for 16 weeks. Trunk stabilising exercises time duration will be 15 minutes. Stance Phase time duration will be 15 minutes.Ankle Strategy. 40 minutes with rest of 5 minutes after 10 minutes.
Intervention Type
Other
Intervention Name(s)
Alexander Technique + Routine Physical Therapy
Intervention Description
Verbal Instructions in Trunk stabilizing exercises. The time duration will be 15 minutes. Verbal instructions in Stance Phase Time duration 15 minutes.Ankle Strategy. 40 minutes with rest of 5 minutes after 10 minutes. Lessons would be two days a week for 16 weeks.
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Intervention Description
Trunk stabilising exercises time duration will be 15 minutes. Stance Phase time duration will be 15 minutes. Ankle Strategy. 40 minutes with rest of 5 minutes after 10 minutes. Two days a week for 16 weeks.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
The balance will be assessed by the Berg balance scale includes fourteen items .(0-20) specifies high fall risk. (21-50) specifies medium fall risk. (41-56) specifies low fall risk.
Time Frame
16 week
Title
Postural Assessment Scale for Stroke
Description
The postural assessment scale for stroke comprised 12 items with a score range of 36. Static and Dynamic PASS rate from 0-3 0 indicates the lowest level of function and 3 indicates the highest level of function.
Time Frame
16 week
Title
Time Up and Go Test
Description
Time up and Go test for measuring Distance of Walking within 10-15 seconds .
Time Frame
16 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Hemorrhagic Hemiplegic Stroke. Age40-60Yrs. Both genders. Intact cognition by MMSE. Muscle tone assessment by Ashworth scale. Right or left side. 6th month onset. Exclusion Criteria: - Dizziness. Vertigo. Cerebellum damage. Hearing impairment. Vision impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Haider Ullah Khan, MS PTN
Phone
03314127210
Email
haiderullah@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Umair Ahmed, MS PTN
Phone
03212700817
Email
umair.ahmed@uipt.uol.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaneez Fatima, MS PTN*
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
NACE
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahid Ahmed Heera, PhD
Phone
03218667920
Email
shahidheera@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25665828
Citation
Cohen RG, Gurfinkel VS, Kwak E, Warden AC, Horak FB. Lighten Up: Specific Postural Instructions Affect Axial Rigidity and Step Initiation in Patients With Parkinson's Disease. Neurorehabil Neural Repair. 2015 Oct;29(9):878-88. doi: 10.1177/1545968315570323. Epub 2015 Feb 9.
Results Reference
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PubMed Identifier
30443528
Citation
Kim S. Exploring the field application of combined cognitive-motor program with mild cognitive impairment elderly patients. J Exerc Rehabil. 2018 Oct 31;14(5):817-820. doi: 10.12965/jer.1836418.209. eCollection 2018 Oct.
Results Reference
background
PubMed Identifier
28637152
Citation
Kal E, van den Brink H, Houdijk H, van der Kamp J, Goossens PH, van Bennekom C, Scherder E. How physical therapists instruct patients with stroke: an observational study on attentional focus during gait rehabilitation after stroke. Disabil Rehabil. 2018 May;40(10):1154-1165. doi: 10.1080/09638288.2017.1290697. Epub 2017 Feb 24.
Results Reference
background
PubMed Identifier
30012397
Citation
Becker JJ, Copeland SL, Botterbusch EL, Cohen RG. Preliminary evidence for feasibility, efficacy, and mechanisms of Alexander technique group classes for chronic neck pain. Complement Ther Med. 2018 Aug;39:80-86. doi: 10.1016/j.ctim.2018.05.012. Epub 2018 May 23.
Results Reference
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Learn more about this trial

Alexander Technique, Routine Physical Therapy, Balance, Posture, Functional Mobility , Chronic, Hemorrhagic, Stroke

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