NCT05255809

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

February 15, 2022

Last Update Submit

March 17, 2022

Conditions

Keywords

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (3)

  • 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.

    16 week

  • 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.

    16 week

  • Time Up and Go Test

    Time up and Go test for measuring Distance of Walking within 10-15 seconds .

    16 week

Study Arms (2)

Alexander Technique + Routine Physical Therapy

EXPERIMENTAL

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.

Other: Alexander Technique + Routine Physical TherapyOther: Routine Physical Therapy

Control Group

PLACEBO COMPARATOR

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.

Other: Routine Physical Therapy

Interventions

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.

Alexander Technique + Routine Physical Therapy

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.

Alexander Technique + Routine Physical TherapyControl Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic Hemorrhagic Hemiplegic Stroke.
  • Age40-60Yrs.
  • Both genders.
  • Intact cognition by MMSE.
  • Muscle tone assessment by Ashworth scale.
  • Right or left side.

You may not qualify if:

  • Dizziness.
  • Vertigo.
  • Cerebellum damage.
  • Hearing impairment.
  • Vision impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NACE

Faisalābad, Punjab Province, 38000, Pakistan

RECRUITING

Related Publications (4)

  • 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.

    PMID: 25665828BACKGROUND
  • 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.

    PMID: 30443528BACKGROUND
  • 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.

    PMID: 28637152BACKGROUND
  • 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.

    PMID: 30012397BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kaneez Fatima, MS PTN*

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Haider Ullah Khan, MS PTN

CONTACT

Umair Ahmed, MS PTN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effects of Alexander Technique In Addition To Routine Physical Therapy On Balance, Posture And Functional Mobility In Chronic Hemorrhagic Stroke: A Randomized Controlled Trial

Study Record Dates

First Submitted

February 15, 2022

First Posted

February 25, 2022

Study Start

December 28, 2021

Primary Completion

September 29, 2022

Study Completion

October 10, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations