Stroke, IschemicNCT06459349
Effects of Sensory Stimulation Versus Sensorimotor Therapy on Spasticity, Motor Function and Daily Activities in Stroke
A study testing exteroceptive and proprioceptive sensory stimulation training and sensorimotor therapy group in people with Stroke, Ischemic and Proprioceptive Disorders, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare effects of exteroceptive and proprioceptive sensory stimulation versus sensorimotor therapy on spasticity, motor function and activities of daily living in patients with stroke Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Stroke, Ischemic, Proprioceptive Disorders, Sensory Defect
- What is being tested?
- exteroceptive and proprioceptive sensory stimulation training and sensorimotor therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 1 Sep 2024
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with chronic stroke (6 months to 2 years)
- Patient 's muscular activity on Stage 3 or higher according to the Brunnstrom's stages of stroke recovery.
- Patients having Mini Mental State Examination score > 24
Who cannot join
- Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
- Any other neurological disorders like multiple sclerosis, Parkinson 's disease.
- History of orthopaedic surgery.
- Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
- Severe visual or vestibular impairments.
- Lower limb prosthesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exteroceptive and Proprioceptive Sensory Stimulation Versus Sensorimotor Therapy on Spasticity, Motor Function and Activities of Daily Living in Patients With Stroke
To compare effects of exteroceptive and proprioceptive sensory stimulation versus sensorimotor therapy on spasticity, motor function and activities of daily living in patients with stroke
Read the detailed description
It will be a randomized clinical trial in which total 42 stroke patients will be recruited through non probability convenience sampling techniques. Data will be collected from Gujranwala Medical College Teaching Hospital and Riphah Rehabilitation Center Lahore. The patients who are fulfilling the inclusion criteria will be randomly assigned to either group A (n=21) which will receive intervention exteroceptive and proprioceptive sensory stimulation or to group B (n=21) which will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks. Baseline treatment will be given to both groups. Conventional therapy will be given for 20 minutes per session, 03 times a week, for 06 weeks. Data collection tools will be Fugl-Meyer Assessment, Modified Barthel Index and Modified Ashworth Scale.
- Conditions
- Stroke, Ischemic, Proprioceptive Disorders, Sensory Defect
- Being tested
- exteroceptive and proprioceptive sensory stimulation training, sensorimotor therapy group
- Keywords
- Stroke, Ischemic, Proprioceptive Disorders, Sensory Defect
- Medical subject headings
- Ischemic Stroke, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exteroceptive and proprioceptive sensory stimulation trainingOther
Patients in this group will receive intervention exteroceptive and proprioceptive sensory stimulation for 50 minutes per session, 03 times a week, for 06 weeks
sensorimotor therapy groupOther
Patients will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks
| Study group | Role | What they receive |
|---|---|---|
| exteroceptive and proprioceptive sensory stimulation | Experimental | Patients in this group will receive exteroceptive and proprioceptive sensory stimulation Receives: Other: exteroceptive and proprioceptive sensory stimulation training |
| sensorimotor therapy group | Active comparator | Patients in this group will receive sensorimotor therapy Receives: Other: sensorimotor therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment
Fugl-Meyer Assessment:
It is designed to evaluate functional recovery after stroke and is based on the poststroke recovery sequence. The test evaluates 5 domains of upper limb, lower limb, balance, sensation, and range of motion in 155 items. The overall reliability was high (overall intraclass correlation coefficient = .96), and the intraclass correlation coefficients for the subsections of the assessment varied from .61 for pain to .97 for the upper extremity. Greater scores refer to improvement in limb functions
Measured: 6 months
Modified Barthel Index:
Modified Barthel Index:
It assesses the level of ability to perform daily activities. This questionnaire measures one's ability to perform different aspects of daily performance on a 0 to 100 scale, with higher scores indicating better performance. 0 to 20 scores are considered as complete dependency, 20 to 60 grades as severe dependency, 61 to 90 as moderate dependency, 91 to 99 as partial dependency and 100 as complete independence.
Measured: 6 months
The Modified Ashworth Scale
The Modified Ashworth Scale is used to assess muscle spasticity. Spasticity using this scale, is the amount of muscle tone that scores between 0 and 4. Score 0 means no increase in tone; score
1 slight increase in muscle tone, with little resistance at the end of the flexion range or extension of involved limb; +1 score slight increase in muscle tone, characterized by slightly resistance at less than half the flexion or extension of involved limb; score 2 significant increase in muscle tone in most limb range;, score 3 significant increase in passive muscle tone, movement is difficult; and score 4 limb involved in flexion or extension rigidity.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Apr 2024
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
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 Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided to group A (n=21) which will receive intervention exteroceptive and proprioceptive sensory stimulation and to group B (n=21) which will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks .
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeest hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459349
- Sponsor's protocol ID
- REC/RCR & AHS/23/0282
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zlokovic BV, Gottesman RF, Bernstein KE, Seshadri S, McKee A, Snyder H, Greenberg SM, Yaffe K, Schaffer CB, Yuan C, Hughes TM, Daemen MJ, Williamson JD, Gonzalez HM, Schneider J, Wellington CL, Katusic ZS, Stoeckel L, Koenig JI, Corriveau RA, Fine L, Galis ZS, Reis J, Wright JD, Chen J. Vascular contributions to cognitive impairment and dementia (VCID): A report from the 2018 National Heart, Lung, and Blood Institute and National Institute of Neurological Disorders and Stroke Workshop. Alzheimers Dement. 2020 Dec;16(12):1714-1733. doi: 10.1002/alz.12157. Epub 2020 Oct 8.
PubMed 33030307Serrada I, Hordacre B, Hillier SL. Does Sensory Retraining Improve Sensation and Sensorimotor Function Following Stroke: A Systematic Review and Meta-Analysis. Front Neurosci. 2019 Apr 30;13:402. doi: 10.3389/fnins.2019.00402. eCollection 2019.
PubMed 31114472Kim KH, Jang SH. Effects of Task-Specific Training after Cognitive Sensorimotor Exercise on Proprioception, Spasticity, and Gait Speed in Stroke Patients: A Randomized Controlled Study. Medicina (Kaunas). 2021 Oct 13;57(10):1098. doi: 10.3390/medicina57101098.
PubMed 34684135
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exteroceptive and Proprioceptive Sensory Stimulation Versus Sensorimotor Therapy on Spasticity, Motor Function and Activities of Daily Living in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06459349
- Acronym / sponsor ID
- REC/RCR & AHS/23/0282
- Conditions
- Stroke, Ischemic, Proprioceptive Disorders, Sensory Defect
- Keywords
- Stroke, Ischemic, Proprioceptive Disorders, Sensory Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 14 Jun 2024 (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 compare effects of exteroceptive and proprioceptive sensory stimulation versus sensorimotor therapy on spasticity, motor function and activities of daily living in patients with stroke
Detailed description
It will be a randomized clinical trial in which total 42 stroke patients will be recruited through non probability convenience sampling techniques. Data will be collected from Gujranwala Medical College Teaching Hospital and Riphah Rehabilitation Center Lahore. The patients who are fulfilling the inclusion criteria will be randomly assigned to either group A (n=21) which will receive intervention exteroceptive and proprioceptive sensory stimulation or to group B (n=21) which will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks. Baseline treatment will be given to both groups. Conventional therapy will be given for 20 minutes per session, 03 times a week, for 06 weeks. Data collection tools will be Fugl-Meyer Assessment, Modified Barthel Index and Modified Ashworth Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be divided to group A (n=21) which will receive intervention exteroceptive and proprioceptive sensory stimulation and to group B (n=21) which will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks .
| Arm | Type | Receives |
|---|---|---|
| exteroceptive and proprioceptive sensory stimulation | Experimental | Other: exteroceptive and proprioceptive sensory stimulation trainingPatients in this group will receive exteroceptive and proprioceptive sensory stimulation |
| sensorimotor therapy group | Active comparator | Other: sensorimotor therapy groupPatients in this group will receive sensorimotor therapy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients with chronic stroke (6 months to 2 years)
- Patient 's muscular activity on Stage 3 or higher according to the Brunnstrom's stages of stroke recovery.
- Patients having Mini Mental State Examination score > 24
Key exclusion criteria (6 listed)
- Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
- Any other neurological disorders like multiple sclerosis, Parkinson 's disease.
- History of orthopaedic surgery.
- Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
- Severe visual or vestibular impairments.
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 |
|---|---|---|
| exteroceptive and proprioceptive sensory stimulation trainingPatients in this group will receive intervention exteroceptive and proprioceptive sensory stimulation for 50 minutes per session, 03 times a week, for 06 weeks | Other | exteroceptive and proprioceptive sensory stimulation |
| sensorimotor therapy groupPatients will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks | Other | sensorimotor therapy group |
Primary outcome
Fugl-Meyer Assessment
Time frame: 6 months
Fugl-Meyer Assessment: It is designed to evaluate functional recovery after stroke and is based on the poststroke recovery sequence. The test evaluates 5 domains of upper limb, lower limb, balance, sensation, and range of motion in 155 items. The overall reliability was high (overall intraclass correlation coefficient = .96), and the intraclass correlation coefficients for the subsections of the assessment varied from .61 for pain to .97 for the upper extremity. Greater scores refer to improvement in limb functions
Modified Barthel Index:
Time frame: 6 months
Modified Barthel Index: It assesses the level of ability to perform daily activities. This questionnaire measures one's ability to perform different aspects of daily performance on a 0 to 100 scale, with higher scores indicating better performance. 0 to 20 scores are considered as complete dependency, 20 to 60 grades as severe dependency, 61 to 90 as moderate dependency, 91 to 99 as partial dependency and 100 as complete independence.
The Modified Ashworth Scale
Time frame: 6 months
The Modified Ashworth Scale is used to assess muscle spasticity. Spasticity using this scale, is the amount of muscle tone that scores between 0 and 4. Score 0 means no increase in tone; score 1 slight increase in muscle tone, with little resistance at the end of the flexion range or extension of involved limb; +1 score slight increase in muscle tone, characterized by slightly resistance at less than half the flexion or extension of involved limb; score 2 significant increase in muscle tone in most limb range;, score 3 significant increase in passive muscle tone, movement is difficult; and score 4 limb involved in flexion or extension rigidity.
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 30 Oct 2024.
- Background: PubMed 33030307Zlokovic BV, Gottesman RF, Bernstein KE, Seshadri S, McKee A, Snyder H, Greenberg SM, Yaffe K, Schaffer CB, Yuan C, Hughes TM, Daemen MJ, Williamson JD, Gonzalez HM, Schneider J, Wellington CL, Katusic ZS, Stoeckel L, Koenig JI, Corriveau RA, Fine L, Galis ZS, Reis J, Wright JD, Chen J. Vascular contributions to cognitive impairment and dementia (VCID): A report from the 2018 National Heart, Lung, and Blood Institute and National Institute of Neurological Disorders and Stroke Workshop. Alzheimers Dement. 2020 Dec;16(12):1714-1733. doi: 10.1002/alz.12157. Epub 2020 Oct 8.
- Background: PubMed 31114472Serrada I, Hordacre B, Hillier SL. Does Sensory Retraining Improve Sensation and Sensorimotor Function Following Stroke: A Systematic Review and Meta-Analysis. Front Neurosci. 2019 Apr 30;13:402. doi: 10.3389/fnins.2019.00402. eCollection 2019.
- Background: PubMed 34684135Kim KH, Jang SH. Effects of Task-Specific Training after Cognitive Sensorimotor Exercise on Proprioception, Spasticity, and Gait Speed in Stroke Patients: A Randomized Controlled Study. Medicina (Kaunas). 2021 Oct 13;57(10):1098. doi: 10.3390/medicina57101098.
- 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.
Zeest hashmi, MSNMPT 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 exteroceptive and proprioceptive sensory stimulation training and sensorimotor therapy group in people with Stroke, Ischemic and Proprioceptive Disorders, 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 3 inclusion and 6 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 30 Oct 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 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?
Fugl-Meyer Assessment (time frame: 6 months). 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 NCT06459349, 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 30 Oct 2024.