StrokeNCT05513781

Investigation of Factors Causing Knee Hyperextension During Walking in Chronic Stroke Patients

An observational study of Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 65 years
Conditions the study is for: Stroke
How many people: 31 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 20 Aug 2022to 15 Nov 2023
Phase: Observational
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Chronic Stroke Patients with Knee Hyperextension

Who may be able to join

Being between the ages of 40-65
At least 6 months have passed since the stroke
Ambulation with or without a walking aid (walker, cane, or tripod)
Being between 0-3 points according to the Modified Rankin Score
Getting a score of 24 or higher on the Mini Mental Test
Presence of hyperextension in the stance phase of gait
Volunteering to participate in the study

Who cannot join

Having a history of more than one stroke
Known presence of dementia
Having a known orthopedic, psychiatric or other neurological disease
Having a situation that prevents communication
Having a history of surgery involving lower extremities and gait

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hacettepe University
Altındağ, Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of Factors Causing Knee Hyperextension During Walking in Chronic Stroke Patients by Electromyographic Method

In this study, it is aimed to examine the factors that cause knee hyperextension in chronic stroke patients. Although the presence of weakness or spasticity in the quadriceps muscle, weakness or spasticity in the plantar flexors, and weakness of the dorsiflexors, hamstrings and gastrocnemius muscle are shown in the literature as the cause of hyperextension of the affected knee in hemiplegic patients, there is a comprehensive study that shows the effect of both muscle strength and spasticity in the lower extremity muscles. there are no studies.

The hypotheses of the study are:

Hypothesis 1:

H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients.

H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients.

Hypothesis 2; H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients.

H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients.

Hypothesis 3; H0: There is no relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients.

H1: There is a relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients.

Conditions: Stroke
Keywords: Gait Analysis, Stroke, Knee Hyperextension, Electromyography
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05513781
Study group	Role	What they receive
Chronic stroke patients with knee hyperextension		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Movement Analysis
Reflective signs will be placed at certain anatomical points of the participants. Participants will be asked to walk a distance of 5 meters. The three-dimensional positions of these reflective marks will be recorded with the 8-camera Vicon motion capture system. Then it will be examined in computer environment using Blade software.
Measured: Baseline
Electromyographic Measurements
Electromyography (EMG) is frequently used in the literature for motion analysis evaluations. It shows the amplitude of the electrical activity of the muscles. In this study, 8-channel Delsys Bagnoli desktop cable electromyography system (Delsys (Delsys Inc., USA)) will be used. EMG; It shows whether the muscles are active during movement, when they are active and how active they are. In this study, the muscles to be measured by EMG: tibialis anterior, medial gastrocnemius, medial hamstrings, rectus femoris, gluteus medius and the lower part of the latismus dorsi are planned.
Measured: Baseline

Secondary outcomes (2)

Muscle Strength Evaluation
Manual muscle testing will be performed on patients' hip flexors, hip extensors, hip abductors, hip adductors, knee flexors, knee extensors, dorsiflexors, and plantar flexors. A score between 0 and 5 will be given according to the manual muscle test, the ability of the muscles to move against gravity in certain positions, and the resistance of the movement against gravity.
Measured: Baseline
Spasticity Evaluation
The spasticity of the lower extremity muscles (quadriceps, hip extensors, hip adductors, hip internal retractors and plantar flexors) will be evaluated according to the Modified Ashworth Scale. The spasticity assessment will be scored between 0 and 4 according to the resistance of the muscles to passive movement.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 202215 Nov 2023

First posted24 Aug 2022
Study start20 Aug 2022
Primary completion11 Oct 2023
Study completion15 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by Hacettepe UniversityThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05513781
Sponsor's protocol ID: E-59394181-604.01.02-39134
Status last verified: Feb 2024
First submitted: 22 Aug 2022
Last updated: 28 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Moseley A, Wales A, Herbert R, Schurr K, Moore S. Observation and analysis of hemiplegic gait: stance phase. Aust J Physiother. 1993;39(4):259-67. doi: 10.1016/S0004-9514(14)60486-4.
PubMed 25026421
Roth EJ, Merbitz C, Mroczek K, Dugan SA, Suh WW. Hemiplegic gait. Relationships between walking speed and other temporal parameters. Am J Phys Med Rehabil. 1997 Mar-Apr;76(2):128-33. doi: 10.1097/00002060-199703000-00008.
PubMed 9129519
Cooper A, Alghamdi GA, Alghamdi MA, Altowaijri A, Richardson S. The relationship of lower limb muscle strength and knee joint hyperextension during the stance phase of gait in hemiparetic stroke patients. Physiother Res Int. 2012 Sep;17(3):150-6. doi: 10.1002/pri.528. Epub 2011 Dec 7.
PubMed 22147298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Factors Causing Knee Hyperextension During Walking in Chronic Stroke Patients by Electromyographic Method
ClinicalTrials.gov ID: NCT05513781
Acronym / sponsor ID: E-59394181-604.01.02-39134
Conditions: Stroke
Keywords: Gait Analysis, Stroke, Knee Hyperextension, Electromyography
Study type: Observational
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Hacettepe UniversityUniversity, hospital or other
Collaborators: Atılım University
Study start: 20 Aug 2022 (actual)
Primary completion: 11 Oct 2023 (actual)
Study completion: 15 Nov 2023 (actual)
First posted: 24 Aug 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.

The hypotheses of the study are:

Hypothesis 1:

H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients.

H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients.

Hypothesis 2; H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients.

H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients.

Hypothesis 3; H0: There is no relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients.

H1: There is a relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Chronic stroke patients with knee hyperextension	–	–

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Chronic Stroke Patients with Knee Hyperextension

Key inclusion criteria (7 listed)

Being between the ages of 40-65
At least 6 months have passed since the stroke
Ambulation with or without a walking aid (walker, cane, or tripod)
Being between 0-3 points according to the Modified Rankin Score
Getting a score of 24 or higher on the Mini Mental Test

Key exclusion criteria (5 listed)

Having a history of more than one stroke
Known presence of dementia
Having a known orthopedic, psychiatric or other neurological disease
Having a situation that prevents communication
Having a history of surgery involving lower extremities and gait

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Movement Analysis
Time frame: Baseline
Reflective signs will be placed at certain anatomical points of the participants. Participants will be asked to walk a distance of 5 meters. The three-dimensional positions of these reflective marks will be recorded with the 8-camera Vicon motion capture system. Then it will be examined in computer environment using Blade software.
Electromyographic Measurements
Time frame: Baseline
Electromyography (EMG) is frequently used in the literature for motion analysis evaluations. It shows the amplitude of the electrical activity of the muscles. In this study, 8-channel Delsys Bagnoli desktop cable electromyography system (Delsys (Delsys Inc., USA)) will be used. EMG; It shows whether the muscles are active during movement, when they are active and how active they are. In this study, the muscles to be measured by EMG: tibialis anterior, medial gastrocnemius, medial hamstrings, rectus femoris, gluteus medius and the lower part of the latismus dorsi are planned.

2 secondary outcomes

Muscle Strength Evaluation
Time frame: Baseline
Spasticity Evaluation
Time frame: Baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Background: PubMed 25026421Moseley A, Wales A, Herbert R, Schurr K, Moore S. Observation and analysis of hemiplegic gait: stance phase. Aust J Physiother. 1993;39(4):259-67. doi: 10.1016/S0004-9514(14)60486-4.
Background: PubMed 9129519Roth EJ, Merbitz C, Mroczek K, Dugan SA, Suh WW. Hemiplegic gait. Relationships between walking speed and other temporal parameters. Am J Phys Med Rehabil. 1997 Mar-Apr;76(2):128-33. doi: 10.1097/00002060-199703000-00008.
Background: PubMed 22147298Cooper A, Alghamdi GA, Alghamdi MA, Altowaijri A, Richardson S. The relationship of lower limb muscle strength and knee joint hyperextension during the stance phase of gait in hemiparetic stroke patients. Physiother Res Int. 2012 Sep;17(3):150-6. doi: 10.1002/pri.528. Epub 2011 Dec 7.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

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.

Kadriye Armutlu, Prof. Dr. study chair

Hacettepe University

Süleyman Korkusuz, MSc principal investigator

Hacettepe University

Sibel Kibar, Assoc. Prof. study chair

Atılım University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).

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 7 inclusion and 5 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Turkey (Türkiye). 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement Analysis (time frame: Baseline). The study lists 2 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 NCT05513781, which also lists 3 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 28 Feb 2024.