Spasticity as Sequela of StrokeNCT04707755
Motor Imagery Technique on Lower Limb Function Among Stroke Patients.
A study testing Motor imagery technique and Conventional Physical Therapy in people with Spasticity as Sequela of Stroke and Gait, Hemiplegic, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of motor imagery technique on lower limb function among stroke patient. To determine the effects of motor imagery technique on lower limb spasticity among stroke patients. To determine the effects of motor imagery technique on gait among stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Spasticity as Sequela of Stroke, Gait, Hemiplegic, Quality of Life
- What is being tested?
- Motor imagery technique and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2020to 30 Nov 2020
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult without ADHD by Adult ADHD Self-Report Scale score.
- History of no more than one stroke.
- Lower limb muscles spasticity with the grade 1+ or 2 on modified Ashworth in scale.
- Mini-mental status score more than 25.
- Patients who are less than 6 months post-stroke.
- Modified Rankin scale score is 4.
Who cannot join
- Lesion of frontal, parietal and basal ganglia
- Excessive spasticity that is score of>3 on modified Ashworth spasticity scale.
- Any musculoskeletal disorder impeding lower limb function.
- Participating in any experimental rehabilitation or drug studies.
- Bed ridden patient.
- Subjects psychiatric disorder or dementia.
- Any neglect of space on the affected side, or any other neurological disease or auditory or visual.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Motor Imagery Technique on Lower Limb Function Among Stroke Patients.
To determine the effects of motor imagery technique on lower limb function among stroke patient.
To determine the effects of motor imagery technique on lower limb spasticity among stroke patients.
To determine the effects of motor imagery technique on gait among stroke patients.
To determine the effects of motor imagery technique on quality of life among stroke patients
Read the detailed description
Stroke affected the functional capacities and the state of health thus altered quality of life.
- Being tested
- Motor imagery technique, Conventional Physical Therapy
- Keywords
- Gait, Lower Limb function, Motor imagery
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery techniqueOther
The patient will sit on chair in a quiet room. The patients will be observing motor performance in video, motor performance video will consist of (1) knee flexion and extension movement, (2) sitting to standing movement, (3) stepping movement, (4) walking, (5) climbing and descending stairs.
Addition to motor imagery, the patients will be provided the passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.
Conventional Physical TherapyOther
It includes passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery technique | Experimental | Motor Imagery technique Plus Conventional Physical therapy Receives: Other: Motor imagery technique |
| Conventional Physical therapy | Active comparator | passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Function scale
It is 20 items questionnaire, measure the lower extremity function scoring from 1 to 4 for each items, in which minimum score is 0 and maximum score of 80 shows the maximum functional status. It has a valid and reliable tool to measure the lower extremity functional status.
Measured: 8 weeks
Dynamic Gait Index
It assess gait, balance and fall risk, with 24 is the maximum score, in which 19 or less have been related to increase incidence of falls. It has high reliability and validity in the stroke population.
Measured: 8 weeks
Time Up and Go test
It assess a person's mobility and requires both static and dynamic balance. Score of less than 10 seconds indicate freely mobile,<20 seconds mostly independent, 20-29 seconds variable mobility, >30 seconds Impaired mobility. It is reliable, valid, and easy to administer clinical tool in stroke patients.
Measured: 8 weeks
Stroke Specific Quality of Life Scale
It is a self-report questionnaire, measure the quality of life in stroke patients consisting of 49 items in the 12 domains. Scoring from 1 to 5 , in which 1 shows strongly agreement and 5 shows strongly disagreement. It is a reliable and valid tool for measuring the quality of life for stroke patients.
Measured: 8 Weeks
Modified Ashworth scale
It measures the spasticity, ranging from 0 means normal tone to 4 shows increased tone to such extent where passive movement is not possible. It has good intra-rater reliability and validity in stroke patients .
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start30 Aug 2020
- Primary completion28 Nov 2020
- Study completion30 Nov 2020
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 Spasticity as Sequela of 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT(NMR), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707755
- Sponsor's protocol ID
- REC00664 Izharuddin
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gul I, Malik MS, Halim A, Rauf S. POST STROKE DEPRESSION: EXPERIENCE AT A TERTIARY CARE HOSPITAL OF PAKISTAN. Pakistan Armed Forces Medical Journal. 2019 Aug 27;69(4):779-83.
Paravlic AH, Pisot R, Marusic U. Specific and general adaptations following motor imagery practice focused on muscle strength in total knee arthroplasty rehabilitation: A randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0221089. doi: 10.1371/journal.pone.0221089. eCollection 2019.
PubMed 31412056Pedersen SG, Heiberg GA, Nielsen JF, Friborg O, Stabel HH, Anke A, Arntzen C. Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale. SAGE Open Med. 2018 Jan 8;6:2050312117752031. doi: 10.1177/2050312117752031. eCollection 2018.
PubMed 29344360
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery Technique on Lower Limb Function Among Stroke Patients.
- ClinicalTrials.gov ID
- NCT04707755
- Acronym / sponsor ID
- REC00664 Izharuddin
- Keywords
- Gait, Lower Limb function, Motor imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 13 Jan 2021 (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.
To determine the effects of motor imagery technique on lower limb function among stroke patient.
To determine the effects of motor imagery technique on lower limb spasticity among stroke patients.
To determine the effects of motor imagery technique on gait among stroke patients.
To determine the effects of motor imagery technique on quality of life among stroke patients
Detailed description
Stroke affected the functional capacities and the state of health thus altered quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor imagery technique | Experimental | Other: Motor imagery techniqueMotor Imagery technique Plus Conventional Physical therapy |
| Conventional Physical therapy | Active comparator | Other: Conventional Physical Therapypassive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult without ADHD by Adult ADHD Self-Report Scale score.
- History of no more than one stroke.
- Lower limb muscles spasticity with the grade 1+ or 2 on modified Ashworth in scale.
- Mini-mental status score more than 25.
- Patients who are less than 6 months post-stroke.
Key exclusion criteria (7 listed)
- Lesion of frontal, parietal and basal ganglia
- Excessive spasticity that is score of>3 on modified Ashworth spasticity scale.
- Any musculoskeletal disorder impeding lower limb function.
- Participating in any experimental rehabilitation or drug studies.
- Bed ridden patient.
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 |
|---|---|---|
| Motor imagery techniqueThe patient will sit on chair in a quiet room. The patients will be observing motor performance in video, motor performance video will consist of (1) knee flexion and extension movement, (2) sitting to standing movement, (3) stepping movement, (4) walking, (5) climbing and descending stairs. Addition to motor imagery, the patients will be provided the passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs. | Other | Motor imagery technique |
| Conventional Physical TherapyIt includes passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs. | Other | Conventional Physical therapy |
Primary outcome
Lower Extremity Function scale
Time frame: 8 weeks
It is 20 items questionnaire, measure the lower extremity function scoring from 1 to 4 for each items, in which minimum score is 0 and maximum score of 80 shows the maximum functional status. It has a valid and reliable tool to measure the lower extremity functional status.
Dynamic Gait Index
Time frame: 8 weeks
It assess gait, balance and fall risk, with 24 is the maximum score, in which 19 or less have been related to increase incidence of falls. It has high reliability and validity in the stroke population.
Time Up and Go test
Time frame: 8 weeks
It assess a person's mobility and requires both static and dynamic balance. Score of less than 10 seconds indicate freely mobile,<20 seconds mostly independent, 20-29 seconds variable mobility, >30 seconds Impaired mobility. It is reliable, valid, and easy to administer clinical tool in stroke patients.
Stroke Specific Quality of Life Scale
Time frame: 8 Weeks
It is a self-report questionnaire, measure the quality of life in stroke patients consisting of 49 items in the 12 domains. Scoring from 1 to 5 , in which 1 shows strongly agreement and 5 shows strongly disagreement. It is a reliable and valid tool for measuring the quality of life for stroke patients.
Modified Ashworth scale
Time frame: 8 Weeks
It measures the spasticity, ranging from 0 means normal tone to 4 shows increased tone to such extent where passive movement is not possible. It has good intra-rater reliability and validity in stroke patients .
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 13 Jan 2021.
- BackgroundGul I, Malik MS, Halim A, Rauf S. POST STROKE DEPRESSION: EXPERIENCE AT A TERTIARY CARE HOSPITAL OF PAKISTAN. Pakistan Armed Forces Medical Journal. 2019 Aug 27;69(4):779-83.
- Background: PubMed 31412056Paravlic AH, Pisot R, Marusic U. Specific and general adaptations following motor imagery practice focused on muscle strength in total knee arthroplasty rehabilitation: A randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0221089. doi: 10.1371/journal.pone.0221089. eCollection 2019.
- Background: PubMed 29344360Pedersen SG, Heiberg GA, Nielsen JF, Friborg O, Stabel HH, Anke A, Arntzen C. Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale. SAGE Open Med. 2018 Jan 8;6:2050312117752031. doi: 10.1177/2050312117752031. eCollection 2018.
- 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.
Mirza Obaid Baig, MSPT(NMR) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery technique and Conventional Physical Therapy in people with Spasticity as Sequela of Stroke and Gait, Hemiplegic, run by Riphah International University 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 6 inclusion and 7 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 13 Jan 2021. 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. 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?
Lower Extremity Function scale (time frame: 8 weeks). The study lists 5 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 NCT04707755, 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 13 Jan 2021.