StrokeNCT02353520
"Reliability of Motricity Index Strength Assessments for Upper Extremity in Post Stroke Hemiparesis- a Correlation Study''
An observational study of Stroke, run by Maharishi Markendeswar University (Deemed to be University).
Trial summary
Initially, a written consent was obtained from each participant. Then they became familiar with the procedure. For intrarater reliability, the first rater assessed the strength of pinch grip, elbow flexion and shoulder abduction in three different sessions at short intervals on same day in same environmental… Read more about this study
- Who is it for?
- Ages 37 to 76 years
- Conditions the study is for
- Stroke
- What is being tested?
- motricity index strength assessment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 2014
- 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 37 to 76 years
- No healthy volunteers
- Adult, Older adult
Study population: stroke patients of both sex
Who may be able to join
- Post stroke hemiparetic patients were included in the study.
- Age 37 to 76 years.
- Mini mental status examination score ≥ 23.
- Individuals having Brunnstrom stage 4 and 5 in upper extremity.
- Individuals should not be taking any physiotherapy treatment for stroke
Who cannot join
- Patients at the acute or chronic commonly seen at clinics.
- Patient having any musculo-skeletal disorder in upper limb.
- Patient having any trauma on their upper extremity.
- Patient having any neurological disorder other than stroke.
- Any hypersensitivity or hyposensitivity disorder
About this study
Initially, a written consent was obtained from each participant. Then they became familiar with the procedure. For intrarater reliability, the first rater assessed the strength of pinch grip, elbow flexion and shoulder abduction in three different sessions at short intervals on same day in same environmental conditions. All the assessments were performed on the same day in three sessions. Assessment duration of all the sessions was 5 minutes.
For inter-rater reliability, Before the beginning of Procedure both the raters were familiarized with the motricity index. The motricity index was administered by two different raters on the same subjects within 2 days who were blind to each others results and heir results were recorded separately.
Read the detailed description
Initially, a written consent was obtained from each participant. Then they became familiar with the procedure. For intrarater reliability, the first rater assessed the strength of pinch grip, elbow flexion and shoulder abduction in three different sessions at short intervals on same day in same environmental conditions. All the assessments were performed on the same day in three sessions. Assessment duration of all the sessions was 5 minutes.
For inter-rater reliability, Before the beginning of Procedure both the raters were familiarized with the motricity index. The motricity index was administered by two different raters on the same subjects within 2 days who were blind to each others results and heir results were recorded separately.
PATIENT POSITION The patient was sitting on a chair or on the edge of the bed, but can be tested lying supine if necessary. In the arm the three movements tested were pinch grip, elbow flexion and shoulder abduction.
Pinch grip Assessed by asking the patient to grip a 2.5 cm cube between the thumb and fore finger. The object was on a flat surface (for example, a book).
The tester scored contraction of any forearm or small hand muscles as follows:
0 No movement. 11 Beginnings of prehension (any movement of finger or thumb). 19 Able to grip the cube, but not hold it against gravity (examiner may need to lift the wrist) 22 Able to grip and hold the cube against gravity, but not against a weak pull.
26 Able to grip and hold the cube against a weak pull, but weaker than the other side.
33 Normal pinch grips. Elbow flexion The elbow was tested with the elbow flexed to 90°, forearm horizontal and upper arm vertical. The patient was asked to bend the elbow so that the hand touches the shoulder. The examiner resisted with a hand on the wrist, and monitored the biceps. If there was no movement, the examiner holded the elbow out so that the arm was horizontal, and gave a score of 14 if movement was then seen.
Shoulder abduction The elbow was fully flexed and against the chest and the patient was asked to abduct the arm. The examiner monitored contraction of the deltoid movement of shoulder girdle does not count-there must be movement of humerus in relation to scapula). A score of 19 was given when the shoulder was abducted to more than 90◦ beyond the horizontal against gravity but not against resistance.
According to the quality of muscle contraction the score was recorded. Rater was also aware of any trick motion such as leaning the back during the movement by placing one hand on their back. Finally, all three scores were summed and the Motricity Index for upper extremity was calculated.
- Conditions
- Stroke
- Being tested
- motricity index strength assessment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motricity index strength assessmentOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Motricity index strength assessment
Initially, a written consent was obtained from each participant. Then they became familiar with the procedure. For intrarater reliability, the first rater assessed the strength of pinch grip, elbow flexion and shoulder abduction in three different sessions at short intervals on same day in same environmental conditions. All the assessments were performed on the same day in three sessions. Assessment duration of all the sessions was 5 minutes.
For inter-rater reliability, Before the beginning of Procedure both the raters were familiarized with the motricity index. The motricity index was administered by two different raters on the same subjects within 2 days who were blind to each others results and heir results were recorded separately.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASHIMA ARORA, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Dr. Senthil P Kumar, PhD, Study director, MMIPR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353520
- Sponsor's protocol ID
- RELIBILITY OF MOTRICITY INDEX
- Status last verified
- Jan 2015
- First submitted
- 28 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Reliability of Motricity Index Strength Assessments for Upper Extremity in Post Stroke Hemiparesis- a Correlation Study''
- ClinicalTrials.gov ID
- NCT02353520
- Acronym / sponsor ID
- RELIBILITY OF MOTRICITY INDEX
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Feb 2015 (estimated)
- 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.
Initially, a written consent was obtained from each participant. Then they became familiar with the procedure. For intrarater reliability, the first rater assessed the strength of pinch grip, elbow flexion and shoulder abduction in three different sessions at short intervals on same day in same environmental conditions. All the assessments were performed on the same day in three sessions. Assessment duration of all the sessions was 5 minutes.
For inter-rater reliability, Before the beginning of Procedure both the raters were familiarized with the motricity index. The motricity index was administered by two different raters on the same subjects within 2 days who were blind to each others results and heir results were recorded separately.
Detailed description
Initially, a written consent was obtained from each participant. Then they became familiar with the procedure. For intrarater reliability, the first rater assessed the strength of pinch grip, elbow flexion and shoulder abduction in three different sessions at short intervals on same day in same environmental conditions. All the assessments were performed on the same day in three sessions. Assessment duration of all the sessions was 5 minutes.
For inter-rater reliability, Before the beginning of Procedure both the raters were familiarized with the motricity index. The motricity index was administered by two different raters on the same subjects within 2 days who were blind to each others results and heir results were recorded separately.
PATIENT POSITION The patient was sitting on a chair or on the edge of the bed, but can be tested lying supine if necessary. In the arm the three movements tested were pinch grip, elbow flexion and shoulder abduction.
Pinch grip Assessed by asking the patient to grip a 2.5 cm cube between the thumb and fore finger. The object was on a flat surface (for example, a book).
The tester scored contraction of any forearm or small hand muscles as follows:
0 No movement. 11 Beginnings of prehension (any movement of finger or thumb). 19 Able to grip the cube, but not hold it against gravity (examiner may need to lift the wrist) 22 Able to grip and hold the cube against gravity, but not against a weak pull.
26 Able to grip and hold the cube against a weak pull, but weaker than the other side.
33 Normal pinch grips. Elbow flexion The elbow was tested with the elbow flexed to 90°, forearm horizontal and upper arm vertical. The patient was asked to bend the elbow so that the hand touches the shoulder. The examiner resisted with a hand on the wrist, and monitored the biceps. If there was no movement, the examiner holded the elbow out so that the arm was horizontal, and gave a score of 14 if movement was then seen.
Shoulder abduction The elbow was fully flexed and against the chest and the patient was asked to abduct the arm. The examiner monitored contraction of the deltoid movement of shoulder girdle does not count-there must be movement of humerus in relation to scapula). A score of 19 was given when the shoulder was abducted to more than 90◦ beyond the horizontal against gravity but not against resistance.
According to the quality of muscle contraction the score was recorded. Rater was also aware of any trick motion such as leaning the back during the movement by placing one hand on their back. Finally, all three scores were summed and the Motricity Index for upper extremity was calculated.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 37 to 76 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients of both sex
Key inclusion criteria (5 listed)
- Post stroke hemiparetic patients were included in the study.
- Age 37 to 76 years.
- Mini mental status examination score ≥ 23.
- Individuals having Brunnstrom stage 4 and 5 in upper extremity.
- Individuals should not be taking any physiotherapy treatment for stroke
Key exclusion criteria (5 listed)
- Patients at the acute or chronic commonly seen at clinics.
- Patient having any musculo-skeletal disorder in upper limb.
- Patient having any trauma on their upper extremity.
- Patient having any neurological disorder other than stroke.
- Any hypersensitivity or hyposensitivity disorder
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 |
|---|---|---|
| motricity index strength assessment | Other | – |
Primary outcome
Motricity index strength assessment
Time frame: 1 month
Initially, a written consent was obtained from each participant. Then they became familiar with the procedure. For intrarater reliability, the first rater assessed the strength of pinch grip, elbow flexion and shoulder abduction in three different sessions at short intervals on same day in same environmental conditions. All the assessments were performed on the same day in three sessions. Assessment duration of all the sessions was 5 minutes. For inter-rater reliability, Before the beginning of Procedure both the raters were familiarized with the motricity index. The motricity index was administered by two different raters on the same subjects within 2 days who were blind to each others results and heir results were recorded separately.
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 2 Feb 2015.
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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.
Dr. Senthil P Kumar, PhD study director
MMIPR
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Maharishi Markendeswar University (Deemed to be University).
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 5 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 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Motricity index strength assessment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2015.