StrokeNCT06927284
Effects Of Neurocognitive Therapy With And Without Soft Robotic Hand On Hand Function
A study testing Neurocognitive Therapy with Soft Robotic Hand and Neurocognitive Therapy without Soft Robotic Hand in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effect of neurocognitive therapy with and without a soft robotic hand on manual ability, dexterity, strength, spasticity and upper limb function in sub-acute stroke. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Neurocognitive Therapy with Soft Robotic Hand and Neurocognitive Therapy without Soft Robotic Hand
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants of Post stroke patients (6-12 weeks )
- Participants with Spasticity < 2 on modified Ashworth scale.
- Participants with first ever stroke.
- Participants with normal cognition > 24 on MoCA
- Participants must be able to provide informed consent
- Hemiparesis with arm motor deficit as assessed by with NIHSS >1(14)
Who cannot join
- Participants who have a history of significant neurological or orthopedic disorders, other than stroke, that could interfere with upper limb motor or sensory recovery.
- Participants who have altered state of consciousness, severe aphasia, severe cognitive deficit.
- Participants who have severe pathologies of traumatic and or rheumatic nature, severe pain in effected arm (>5 on visual analog scale for pain) .
- Participants who have active pacemakers and other active implants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Sheikh Zayad Hospital
Lahore, Punjab Province
Aruba Saeed, PhD, 03344399403, aruba.saeed@riphah.edu.pk
Shazia Abdul Mateen, MS NMPT
About this study
Official title: Effects of Neurocognitive Therapy With and Without Soft Robotic Hand on Hand Function in Sub-acute Stroke
To determine the effect of neurocognitive therapy with and without a soft robotic hand on manual ability, dexterity, strength, spasticity and upper limb function in sub-acute stroke.
Read the detailed description
Stroke is a global disease with high death rate and high disability caused by motor cortical damage. According to the calculations, there were approximately 13.68 million new increased stroke patients all over the world a year and about 70% of survivors had different degrees of upper limb and hand movement dysfunction .The recovery rate of patients' motor function mainly depends on rehabilitation training. Therefore, due to individual difference of patients. Neurocognitive therapy is an effective therapy to improve and increase cognitive, sensory and motor function of upper limb. Robotic hand also help the function of weak hand muscle. Neurocognitive therapy with a robotic hand will have the potential to offer targeted, precise, and adaptable interventions, possibly increase the rehabilitation process compared to both interventions alone. Evaluating their relative efficacy will aid in refining and tailoring rehabilitation strategies for individuals recovering from acute stroke.
- Conditions
- Stroke
- Being tested
- Neurocognitive Therapy with Soft Robotic Hand, Neurocognitive Therapy without Soft Robotic Hand
- Keywords
- Hand Function, Cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive Therapy with Soft Robotic HandOther
There will be 23 participants received Neurocognitive Therapy with soft robotic hand . Total 45 minutes session will be provided to patient including 15 minutes of routine physical therapy training for upper limb. The following hand exercises will be performed . Passive localization, passive identification, and active object exploration .For localization placed a part of the patient's limb, typically the fingertip, on one external object (e.g. sand paper, toothpick, sponge, paint brush, cotton ball, pencil, eraser ) and for identification water bottle, sponge, toothpaste tube, electrical plug, plastic ball, paper cup, tape roll, metal bolt with nut, tape roll . During active exploration the The training object repositioned, and another object of a different shape or size offered (water bottle, water bottle with ice in it, sponge. The blindfolded patient then used his effected hand to explore different objects and asked to identify each object with soft robotic hand.
Neurocognitive Therapy without Soft Robotic HandOther
There will be 23 participants received Neurocognitive Therapy without soft robotic hand . Total 45 minutes session will be provided to patient including 15 minutes of routine physical therapy training for upper limb. The following hand exercises will be performed . Passive localization, passive identification, and active object exploration .For localization placed a part of the patient's limb, typically the fingertip, on one external object (e.g. sand paper, toothpick, sponge, paint brush, cotton ball, pencil, eraser ) and for identification water bottle, sponge, toothpaste tube, electrical plug, plastic ball, paper cup, tape roll, metal bolt with nut, tape roll . During active exploration the The training object will be repositioned, and another object of a different shape or size will be offered (water bottle, water bottle with ice in it, sponge. The blindfolded patient then used his effected hand to explore different objects and asked to identify each object .
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive Therapy with Soft Robotic Hand based | Experimental | Neurocognitive therapy group with soft robotic hand for 30 minutes along routine physical therapy for 15 minutes , the participants will be blindfolded during the exercises and ask to concentrate on sensing the position of the limb and hand Opening and closing of the soft robotic glove is controlled by the hand control switch .Treatment session of 45 minutes will be given 3 times a week for 12 week. Receives: Other: Neurocognitive Therapy without Soft Robotic Hand |
| Neurocognitive Therapy without Soft Robotic Hand based | Experimental | Neurocognitive therapy group without soft robotic hand for 30 minutes along routine physical therapy for 15 minutes , the participants will be blindfolded during the exercises and ask to concentrate on sensing the position of the limb and hand Opening and closing of the soft robotic glove is controlled by the hand control switch .Treatment session of 45 minutes will be given 3 times a week for 12 week. Receives: Other: Neurocognitive Therapy with Soft Robotic Hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal cognitive assessment (MoCA): (cognition)
The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal. Inter-rater Reliability (0.96) Cronbach's alpha .Change will be measured from baseline to 12 weeks.
Measured: 12 Weeks
Barthel Index (basic activities of daily living)
The BI is a measure of functional status whose validity when used on a general population of older people has been shown . The BI uses 10 items . Of the 10 items, two (bathing and grooming) are rated on a two-point scale of 0 and 1, six (feeding, dressing, bowels, bladder, toilet use and stairs) on a three-point scale of 0, 1 and 2 and the last two items (transfers and mobility) are rated on a four-point scale of 0, 1, 2 and 3. Change will be measured from baseline to 12 weeks.
Measured: 12 Weeks
Modified Ashworth Scale (MAS)( spasticity level of the upper limb)
The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. In 1987, while performing a study to exam interrater reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the Ashworth scale by adding 1+ to the scale to increase sensitivity. Change will be measured from baseline to 12 weeks.
Measured: 12 Weeks
Erasmus MC Nottingham Sensory Assessment (ErNSA) (sensation and proprioceptive)
The ErNSA is a specialized assessment tool designed to evaluate tactile sensation and proprioceptive ability in the upper limb. It consists of various subtests that provide a detailed examination of sensory function, contributing valuable insights into the sensory recovery post stroke of the upper limb).Change will be measured from bassline to 12 weeks.
Measured: 12 Weeks
) Action Research Arm Test (grasping, grip- ping, pinching)
The ARAT is a hierarchical scale for the evaluation of arm-hand capacity. It consists of 19 functional items that are divided into 4 subtests: grasp, pinch, grip, and gross motor function. A total score of 57 indicates normative performance. The reliability and validity of the ARAT for patients with stroke have been established. on ARAT scores and subsequently classified into 5 different categories: 0 to 10 points as no capacity, 11 to 21 points as poor capacity, 22 to 42 points as limited capacity, 43 to 54 points as notable capacity, and 55 to 57 points as full capacity. Change will be measured from baseline to 12 weeks.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Apr 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
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.
- 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
- Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD*, Principal investigator, Riphah International UniversityShazia Abdul Mateen, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927284
- Sponsor's protocol ID
- REC/0217 Shazia
- Status last verified
- Aug 2025
- First submitted
- 7 Apr 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurocognitive Therapy With and Without Soft Robotic Hand on Hand Function in Sub-acute Stroke
- ClinicalTrials.gov ID
- NCT06927284
- Acronym / sponsor ID
- REC/0217 Shazia
- Conditions
- Stroke
- Keywords
- Hand Function, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Apr 2025 (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 effect of neurocognitive therapy with and without a soft robotic hand on manual ability, dexterity, strength, spasticity and upper limb function in sub-acute stroke.
Detailed description
Stroke is a global disease with high death rate and high disability caused by motor cortical damage. According to the calculations, there were approximately 13.68 million new increased stroke patients all over the world a year and about 70% of survivors had different degrees of upper limb and hand movement dysfunction .The recovery rate of patients' motor function mainly depends on rehabilitation training. Therefore, due to individual difference of patients. Neurocognitive therapy is an effective therapy to improve and increase cognitive, sensory and motor function of upper limb. Robotic hand also help the function of weak hand muscle. Neurocognitive therapy with a robotic hand will have the potential to offer targeted, precise, and adaptable interventions, possibly increase the rehabilitation process compared to both interventions alone. Evaluating their relative efficacy will aid in refining and tailoring rehabilitation strategies for individuals recovering from acute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive Therapy with Soft Robotic Hand based | Experimental | Other: Neurocognitive Therapy without Soft Robotic HandNeurocognitive therapy group with soft robotic hand for 30 minutes along routine physical therapy for 15 minutes , the participants will be blindfolded during the exercises and ask to concentrate on sensing the position of the limb and hand Opening and closing of the soft robotic glove is controlled by the hand control switch .Treatment session of 45 minutes will be given 3 times a week for 12 week. |
| Neurocognitive Therapy without Soft Robotic Hand based | Experimental | Other: Neurocognitive Therapy with Soft Robotic HandNeurocognitive therapy group without soft robotic hand for 30 minutes along routine physical therapy for 15 minutes , the participants will be blindfolded during the exercises and ask to concentrate on sensing the position of the limb and hand Opening and closing of the soft robotic glove is controlled by the hand control switch .Treatment session of 45 minutes will be given 3 times a week for 12 week. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants of Post stroke patients (6-12 weeks )
- Participants with Spasticity < 2 on modified Ashworth scale.
- Participants with first ever stroke.
- Participants with normal cognition > 24 on MoCA
- Participants must be able to provide informed consent
Key exclusion criteria (4 listed)
- Participants who have a history of significant neurological or orthopedic disorders, other than stroke, that could interfere with upper limb motor or sensory recovery.
- Participants who have altered state of consciousness, severe aphasia, severe cognitive deficit.
- Participants who have severe pathologies of traumatic and or rheumatic nature, severe pain in effected arm (>5 on visual analog scale for pain) .
- Participants who have active pacemakers and other active implants.
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 |
|---|---|---|
| Neurocognitive Therapy with Soft Robotic HandThere will be 23 participants received Neurocognitive Therapy with soft robotic hand . Total 45 minutes session will be provided to patient including 15 minutes of routine physical therapy training for upper limb. The following hand exercises will be performed . Passive localization, passive identification, and active object exploration .For localization placed a part of the patient's limb, typically the fingertip, on one external object (e.g. sand paper, toothpick, sponge, paint brush, cotton ball, pencil, eraser ) and for identification water bottle, sponge, toothpaste tube, electrical plug, plastic ball, paper cup, tape roll, metal bolt with nut, tape roll . During active exploration the The training object repositioned, and another object of a different shape or size offered (water bottle, water bottle with ice in it, sponge. The blindfolded patient then used his effected hand to explore different objects and asked to identify each object with soft robotic hand. | Other | Neurocognitive Therapy without Soft Robotic Hand based |
| Neurocognitive Therapy without Soft Robotic HandThere will be 23 participants received Neurocognitive Therapy without soft robotic hand . Total 45 minutes session will be provided to patient including 15 minutes of routine physical therapy training for upper limb. The following hand exercises will be performed . Passive localization, passive identification, and active object exploration .For localization placed a part of the patient's limb, typically the fingertip, on one external object (e.g. sand paper, toothpick, sponge, paint brush, cotton ball, pencil, eraser ) and for identification water bottle, sponge, toothpaste tube, electrical plug, plastic ball, paper cup, tape roll, metal bolt with nut, tape roll . During active exploration the The training object will be repositioned, and another object of a different shape or size will be offered (water bottle, water bottle with ice in it, sponge. The blindfolded patient then used his effected hand to explore different objects and asked to identify each object . | Other | Neurocognitive Therapy with Soft Robotic Hand based |
Primary outcome
Montreal cognitive assessment (MoCA): (cognition)
Time frame: 12 Weeks
The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal. Inter-rater Reliability (0.96) Cronbach's alpha .Change will be measured from baseline to 12 weeks.
Barthel Index (basic activities of daily living)
Time frame: 12 Weeks
The BI is a measure of functional status whose validity when used on a general population of older people has been shown . The BI uses 10 items . Of the 10 items, two (bathing and grooming) are rated on a two-point scale of 0 and 1, six (feeding, dressing, bowels, bladder, toilet use and stairs) on a three-point scale of 0, 1 and 2 and the last two items (transfers and mobility) are rated on a four-point scale of 0, 1, 2 and 3. Change will be measured from baseline to 12 weeks.
Modified Ashworth Scale (MAS)( spasticity level of the upper limb)
Time frame: 12 Weeks
The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. In 1987, while performing a study to exam interrater reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the Ashworth scale by adding 1+ to the scale to increase sensitivity. Change will be measured from baseline to 12 weeks.
Erasmus MC Nottingham Sensory Assessment (ErNSA) (sensation and proprioceptive)
Time frame: 12 Weeks
The ErNSA is a specialized assessment tool designed to evaluate tactile sensation and proprioceptive ability in the upper limb. It consists of various subtests that provide a detailed examination of sensory function, contributing valuable insights into the sensory recovery post stroke of the upper limb).Change will be measured from bassline to 12 weeks.
) Action Research Arm Test (grasping, grip- ping, pinching)
Time frame: 12 Weeks
The ARAT is a hierarchical scale for the evaluation of arm-hand capacity. It consists of 19 functional items that are divided into 4 subtests: grasp, pinch, grip, and gross motor function. A total score of 57 indicates normative performance. The reliability and validity of the ARAT for patients with stroke have been established. on ARAT scores and subsequently classified into 5 different categories: 0 to 10 points as no capacity, 11 to 21 points as poor capacity, 22 to 42 points as limited capacity, 43 to 54 points as notable capacity, and 55 to 57 points as full capacity. Change will be measured from baseline to 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- 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.
Aruba Saeed, PhD* principal investigator
Riphah International University
Shazia Abdul Mateen study chair
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 Neurocognitive Therapy with Soft Robotic Hand and Neurocognitive Therapy without Soft Robotic Hand in people with Stroke, 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 4 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shazia Abdul Mateen, PhD (03344399403, aruba.saeed@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal cognitive assessment (MoCA): (cognition) (time frame: 12 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?
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 22 Aug 2025.