StrokeNCT05087719
Effects of Proprioceptive Activities on Hand Function in Chronic Stroke Patients
A study testing experimental group and conventional treatment in people with Stroke and Proprioceptive Disorders, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine effects of proprioceptive activities on hand function in chronic stroke patients Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke, Proprioceptive Disorders
- What is being tested?
- experimental group and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2020to 15 Aug 2021
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Either right or left sided hemiplegic patients post stroke 6 months to 4 years
- Can partially open and close hand and able to elevate arm to at least 60 degrees and bend to 45-60 degree against gravity.
Who cannot join
- Patient with TBI, neuromuscular degenerative diseases, diabetes, heart disease, fracture of hand ,.muscular skeletal injuries of hand or birth deformities of hand
- Patients having any known or diagnosed psychological condition or unable to follow the command for exercise.
Trial locations and contacts
1 site in 1 country.
About this study
To determine effects of proprioceptive activities on hand function in chronic stroke patients
Read the detailed description
Stroke is causing the long term disability worldwide. The patient in the chronic phase of stroke may suffer from long term hand disability along with both motor and sensory dysfunction. That causes hindrance in performing the ADLs. As the hand is the important organ performing major functions of daily living .So the early restoration of the motor as well as sensory function is necessary.
The motive of this study IS to determine effects of proprioceptive activities on hand function in chronic stroke patients. Total 40 chronic stroke patients will be included in the study. They will be randomly allocated in two groups by lottery method that fulfills the inclusion criteria of the study. In group A patients will be recruited and proprioceptive activities will be given to the affected hand for 3 days /week for 2 months. On the other hand in group B conventional therapy will be given for 3 days /week for 2 months. In sensory training graphesthesia and stereognosis will be checked by modified subtest of sensory integration praxis test and Byl-Cheney-Boczai Sensory Discriminator Test respectively. The motor task will be assessed by the wolf motor test. As a baseline treatment hot pack for 15 min will be given to both of the groups
- Conditions
- Stroke, Proprioceptive Disorders
- Being tested
- experimental group, conventional treatment
- Keywords
- graphesthesia, stereognosis, stroke
- Medical subject headings
- Stroke, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupCombination product
patients will receive the hot pack initially for 15 minutes .Then for proprioception training of graphesthesia for 15 mints,stereognosis will be of 15 minutes. For motor training patients will practice 15 mints motor tasks
conventional treatmentCombination product
patients will receive the baseline treatment of hot pack for 15 minutes. The patients in this group will get muscle strengthening exercise of the hand, Range of motion, and stretching of the hand muscles, 3 sets of 8 repetitions were given to the patient, gap of 2 minutes will be given between regimes. For 20 minutes this session will be given to patient by the therapist.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The patients in the experimental group will get the hot pack initially for 15 minutes .Then for proprioception training of graphesthesia for 15 mints, therapist repeatedly draw some letter, figures, digit, shapes ,alphabets on the palm of hand/digits of patient.For Stereognosis therapist command the patient to close his or her eyes, then on affected hand put some different kinds of objects and shapes then ask the patient to identify that object, the object might be of any kind like a key, rubber a block or a coin etc. Total time for stereognosis was 15 minutes. For motor training patients were guided by the therapist to use his or her affected hand more. Then patient practiced some task like drawing writing his or her name, folding the towel or a paper, eating something with different speed, picking small objects like nails and put them in to small boxes, organize the cards etc. This training session required 15 minutes. Receives: Combination Product: experimental group |
| conventional treatment | Active comparator | baseline treatment of hot pack for 15 minutes will be given.The patients in this group will get muscle strengthening exercise of the hand, Range of motion, and stretching of the hand muscles, 3 sets of 8 repetitions were given to the patient, gap of 2 minutes will be given between regimes. For 20 minutes this session will be given to patient by the therapist. Receives: Combination Product: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
wolf motor assessment scale
The scale was categorized from 0-5.0 represents that UE doesn't attempt tested.1 represents that the UE being tested does not participate functionally.2 represents that UE does movements minor readjustment or change in position, but requires assistance.3 represents UE does movement but movements is effected to certain degree by synergy or performance gradually or with effort.4 represents that movement was close to normal slight slower lack accuracy.5 represents that movement seems to be accurate
Measured: 15 minutes
Byl-Cheney-Boczai Sensory Discriminator Test
For the stereognosis
Measured: 15 minutes
Graphesthesia (modified sub test of sensory integration praxis test)
to assess Graphesthesia
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start15 Oct 2020
- Primary completion15 Jul 2021
- Study completion15 Aug 2021
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 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zeest hashmi, MS NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087719
- Sponsor's protocol ID
- REC/RCR & AHS/20/0208
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu CY, Fu T, Lin KC, Feng CT, Hsieh KP, Yu HW, Lin CH, Hsieh CJ, Ota H. Assessing the streamlined Wolf motor function test as an outcome measure for stroke rehabilitation. Neurorehabil Neural Repair. 2011 Feb;25(2):194-9. doi: 10.1177/1545968310381249. Epub 2010 Oct 14.
PubMed 20947494Turville ML, Cahill LS, Matyas TA, Blennerhassett JM, Carey LM. The effectiveness of somatosensory retraining for improving sensory function in the arm following stroke: a systematic review. Clin Rehabil. 2019 May;33(5):834-846. doi: 10.1177/0269215519829795. Epub 2019 Feb 25.
PubMed 30798643Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.
PubMed 27679565
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Activities on Hand Function in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05087719
- Acronym / sponsor ID
- REC/RCR & AHS/20/0208
- Conditions
- Stroke, Proprioceptive Disorders
- Keywords
- graphesthesia, stereognosis, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 21 Oct 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 effects of proprioceptive activities on hand function in chronic stroke patients
Detailed description
Stroke is causing the long term disability worldwide. The patient in the chronic phase of stroke may suffer from long term hand disability along with both motor and sensory dysfunction. That causes hindrance in performing the ADLs. As the hand is the important organ performing major functions of daily living .So the early restoration of the motor as well as sensory function is necessary.
The motive of this study IS to determine effects of proprioceptive activities on hand function in chronic stroke patients. Total 40 chronic stroke patients will be included in the study. They will be randomly allocated in two groups by lottery method that fulfills the inclusion criteria of the study. In group A patients will be recruited and proprioceptive activities will be given to the affected hand for 3 days /week for 2 months. On the other hand in group B conventional therapy will be given for 3 days /week for 2 months. In sensory training graphesthesia and stereognosis will be checked by modified subtest of sensory integration praxis test and Byl-Cheney-Boczai Sensory Discriminator Test respectively. The motor task will be assessed by the wolf motor test. As a baseline treatment hot pack for 15 min will be given to both of the groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Combination Product: experimental groupThe patients in the experimental group will get the hot pack initially for 15 minutes .Then for proprioception training of graphesthesia for 15 mints, therapist repeatedly draw some letter, figures, digit, shapes ,alphabets on the palm of hand/digits of patient.For Stereognosis therapist command the patient to close his or her eyes, then on affected hand put some different kinds of objects and shapes then ask the patient to identify that object, the object might be of any kind like a key, rubber a block or a coin etc. Total time for stereognosis was 15 minutes. For motor training patients were guided by the therapist to use his or her affected hand more. Then patient practiced some task like drawing writing his or her name, folding the towel or a paper, eating something with different speed, picking small objects like nails and put them in to small boxes, organize the cards etc. This training session required 15 minutes. |
| conventional treatment | Active comparator | Combination Product: conventional treatmentbaseline treatment of hot pack for 15 minutes will be given.The patients in this group will get muscle strengthening exercise of the hand, Range of motion, and stretching of the hand muscles, 3 sets of 8 repetitions were given to the patient, gap of 2 minutes will be given between regimes. For 20 minutes this session will be given to patient by the therapist. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Either right or left sided hemiplegic patients post stroke 6 months to 4 years
- Can partially open and close hand and able to elevate arm to at least 60 degrees and bend to 45-60 degree against gravity.
Key exclusion criteria (2 listed)
- Patient with TBI, neuromuscular degenerative diseases, diabetes, heart disease, fracture of hand ,.muscular skeletal injuries of hand or birth deformities of hand
- Patients having any known or diagnosed psychological condition or unable to follow the command for exercise.
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 |
|---|---|---|
| experimental grouppatients will receive the hot pack initially for 15 minutes .Then for proprioception training of graphesthesia for 15 mints,stereognosis will be of 15 minutes. For motor training patients will practice 15 mints motor tasks | Combination product | experimental group |
| conventional treatmentpatients will receive the baseline treatment of hot pack for 15 minutes. The patients in this group will get muscle strengthening exercise of the hand, Range of motion, and stretching of the hand muscles, 3 sets of 8 repetitions were given to the patient, gap of 2 minutes will be given between regimes. For 20 minutes this session will be given to patient by the therapist. | Combination product | conventional treatment |
Primary outcome
wolf motor assessment scale
Time frame: 15 minutes
The scale was categorized from 0-5.0 represents that UE doesn't attempt tested.1 represents that the UE being tested does not participate functionally.2 represents that UE does movements minor readjustment or change in position, but requires assistance.3 represents UE does movement but movements is effected to certain degree by synergy or performance gradually or with effort.4 represents that movement was close to normal slight slower lack accuracy.5 represents that movement seems to be accurate
Byl-Cheney-Boczai Sensory Discriminator Test
Time frame: 15 minutes
For the stereognosis
Graphesthesia (modified sub test of sensory integration praxis test)
Time frame: 15 minutes
to assess Graphesthesia
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 21 Oct 2021.
- Background: PubMed 20947494Wu CY, Fu T, Lin KC, Feng CT, Hsieh KP, Yu HW, Lin CH, Hsieh CJ, Ota H. Assessing the streamlined Wolf motor function test as an outcome measure for stroke rehabilitation. Neurorehabil Neural Repair. 2011 Feb;25(2):194-9. doi: 10.1177/1545968310381249. Epub 2010 Oct 14.
- Background: PubMed 30798643Turville ML, Cahill LS, Matyas TA, Blennerhassett JM, Carey LM. The effectiveness of somatosensory retraining for improving sensory function in the arm following stroke: a systematic review. Clin Rehabil. 2019 May;33(5):834-846. doi: 10.1177/0269215519829795. Epub 2019 Feb 25.
- Background: PubMed 27679565Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.
- 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, MS NMPT 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 experimental group and conventional treatment in people with Stroke 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 2 inclusion and 2 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 21 Oct 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?
wolf motor assessment scale (time frame: 15 minutes). 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 NCT05087719, 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 21 Oct 2021.