Chronic Hemorrhagic StrokeNCT05255809
Alexander Technique, Routine Physical Therapy, Balance, Posture, Functional Mobility , Chronic, Hemorrhagic, Stroke
A study testing Alexander Technique + Routine Physical Therapy and Routine Physical Therapy in people with Chronic Hemorrhagic Stroke, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Hemorrhagic Stroke
- What is being tested?
- Alexander Technique + Routine Physical Therapy and Routine Physical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Dec 2021to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic Hemorrhagic Hemiplegic Stroke.
- Age40-60Yrs.
- Both genders.
- Intact cognition by MMSE.
- Muscle tone assessment by Ashworth scale.
- Right or left side.
Show all 12Show fewer
- 6th month onset. Exclusion Criteria: -
- Dizziness.
- Vertigo.
- Cerebellum damage.
- Hearing impairment.
- Vision impairment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
NACE
Faisalābad, Punjab Province, 38000
Shahid Ahmed Heera, PhD, 03218667920, shahidheera@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Chronic Hemorrhagic Stroke
- Being tested
- Alexander Technique + Routine Physical Therapy, Routine Physical Therapy
- Keywords
- Cerebrovascular Accident
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alexander Technique + Routine Physical TherapyOther
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.
Routine Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Alexander Technique + Routine Physical Therapy; Other: 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. Receives: Other: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 week
Time Up and Go Test
Time up and Go test for measuring Distance of Walking within 10-15 seconds .
Measured: 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start28 Dec 2021
- Primary completion29 Sep 2022 (estimated)
- Study completion10 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Hemorrhagic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaneez Fatima, University of Lahore
- Investigators
- Kaneez Fatima, MS PTN*, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255809
- Sponsor's protocol ID
- IRB-UOL-FAHS/1087/2021
- Status last verified
- Mar 2022
- First submitted
- 15 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25665828Kim 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.
PubMed 30443528Kal 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.
PubMed 28637152Becker 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.
PubMed 30012397
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05255809
- Acronym / sponsor ID
- IRB-UOL-FAHS/1087/2021
- Conditions
- Chronic Hemorrhagic Stroke
- Keywords
- Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 29 Sep 2022 (estimated)
- Study completion
- 10 Oct 2022 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| Alexander Technique + Routine Physical Therapy | Experimental | Other: Alexander Technique + Routine Physical Therapy, Other: Routine Physical TherapyRoutine 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. |
| Control Group | Placebo comparator | Other: Routine Physical TherapyRoutine 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Chronic Hemorrhagic Hemiplegic Stroke.
- Age40-60Yrs.
- Both genders.
- Intact cognition by MMSE.
- Muscle tone assessment by Ashworth scale.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alexander Technique + Routine Physical TherapyVerbal 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. | Other | Alexander Technique + Routine Physical Therapy |
| Routine Physical TherapyTrunk 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. | Other | Alexander Technique + Routine Physical Therapy, Control Group |
Primary outcome
Berg Balance Scale
Time frame: 16 week
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
Time frame: 16 week
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 frame: 16 week
Time up and Go test for measuring Distance of Walking within 10-15 seconds .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 25665828Cohen 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.
- Background: PubMed 30443528Kim 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.
- Background: PubMed 28637152Kal 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.
- Background: PubMed 30012397Becker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaneez Fatima, MS PTN* principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alexander Technique + Routine Physical Therapy and Routine Physical Therapy in people with Chronic Hemorrhagic Stroke, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Haider Ullah Khan, MS PTN (03314127210, haiderullah@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 16 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05255809, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.