StrokeNCT05916872
Combined Effects of PNF and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.
A study testing experimental group in people with Stroke and Proprioceptive Disorders, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the combined effects of proprioceptive neuromuscular facilitation and electrical muscle stimulation on spasticity and hand function in stroke patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Stroke, Proprioceptive Disorders, Balance; Distorted
- What is being tested?
- experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 15 Sep 2023
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both ischemic and haemorrhagic stroke patients
- Chronic stroke patients from 6 month to 2years
- Mini Mental Scale Examination (MMSE) more than 25
Who cannot join
- Transient ischemic attack
- Recurrent stroke
- Stroke patient with comorbidity and cardiac disease
- Myopathies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Proprioceptive Neuromuscular Facilitation and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.
To determine the combined effects of proprioceptive neuromuscular facilitation and electrical muscle stimulation on spasticity and hand function in stroke patients.
Read the detailed description
It will be a randomized controlled trial. The stroke patients aged between 30-70 years will be included in this study. Participants will be selected with non-probability convenience sampling technique. Participants will be randomly allocated into two groups by lottery method i.e experimental group and control group. The experimental group will receive proprioceptive neuromuscular technique (contract relax-10 repetition) (5-min) and electrical muscle stimulation(10 min) as 15 min session 3 times a week for four weeks while the control group will receive only conventional therapy. The outcome measure will be calculated by modified barthel index, modified ashworth scale and wolf motor function test.
- Conditions
- Stroke, Proprioceptive Disorders, Balance; Distorted
- Being tested
- experimental group, control group
- Keywords
- Stroke, Proprioceptive Disorders, Balance; Distorted
- 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 groupOther
Patients will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique with EMS
control groupOther
Patients will receive conventional therapy.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | patients in this group will receive contract relax exercises along with EMS Receives: Other: experimental group |
| control group | Active comparator | patients in groups B will receive conventional therapy. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Barthel Index:
It is used for assessing the activities of daily living. It is composed of 10 questions that link the degree of independence to daily living activities. Collin et, al; proposed amendment in 1988, in which each domain was scored in one-point increments, ranging from 0 to 2 or 3 for each activity with a maximum score of 20 suggesting functional independence. It is highly reliable and has a good correlation with other disability measures.
Measured: 9 months
Modified Ashworth Scale:
Modified Ashworth Scale:
It is used to assess the spasticity in patients of stroke or spinal cord injury. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity. It is characterized by exaggerated deep tendon reflexes that interfere with muscular activity, gait, movement, or speech. It has excellent validity and reliability.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Nov 2022
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
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
- Model description
- patients will be allocated to two groups by randomization. Patients in Group A will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique \& EMS patients in Group B will receive conventional therapy.
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT05916872
- Sponsor's protocol ID
- REC/RCR & AHS/23/0211
- Status last verified
- Oct 2023
- First submitted
- 14 Jun 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hankey GJ. The global and regional burden of stroke. Lancet Glob Health. 2013 Nov;1(5):e239-40. doi: 10.1016/S2214-109X(13)70095-0. Epub 2013 Oct 24. No abstract available.
PubMed 25104481Faghri PD, Rodgers MM, Glaser RM, Bors JG, Ho C, Akuthota P. The effects of functional electrical stimulation on shoulder subluxation, arm function recovery, and shoulder pain in hemiplegic stroke patients. Arch Phys Med Rehabil. 1994 Jan;75(1):73-9.
PubMed 8291967Rong W, Tong KY, Hu XL, Ho SK. Effects of electromyography-driven robot-aided hand training with neuromuscular electrical stimulation on hand control performance after chronic stroke. Disabil Rehabil Assist Technol. 2015 Mar;10(2):149-59. doi: 10.3109/17483107.2013.873491. Epub 2013 Dec 31.
PubMed 24377757
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Proprioceptive Neuromuscular Facilitation and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.
- ClinicalTrials.gov ID
- NCT05916872
- Acronym / sponsor ID
- REC/RCR & AHS/23/0211
- Conditions
- Stroke, Proprioceptive Disorders, Balance; Distorted
- Keywords
- Stroke, Proprioceptive Disorders, Balance; Distorted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 23 Jun 2023 (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 combined effects of proprioceptive neuromuscular facilitation and electrical muscle stimulation on spasticity and hand function in stroke patients.
Detailed description
It will be a randomized controlled trial. The stroke patients aged between 30-70 years will be included in this study. Participants will be selected with non-probability convenience sampling technique. Participants will be randomly allocated into two groups by lottery method i.e experimental group and control group. The experimental group will receive proprioceptive neuromuscular technique (contract relax-10 repetition) (5-min) and electrical muscle stimulation(10 min) as 15 min session 3 times a week for four weeks while the control group will receive only conventional therapy. The outcome measure will be calculated by modified barthel index, modified ashworth scale and wolf motor function test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients will be allocated to two groups by randomization. Patients in Group A will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique \& EMS patients in Group B will receive conventional therapy.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: experimental grouppatients in this group will receive contract relax exercises along with EMS |
| control group | Active comparator | Other: control grouppatients in groups B will receive conventional therapy. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both ischemic and haemorrhagic stroke patients
- Chronic stroke patients from 6 month to 2years
- Mini Mental Scale Examination (MMSE) more than 25
Key exclusion criteria (4 listed)
- Transient ischemic attack
- Recurrent stroke
- Stroke patient with comorbidity and cardiac disease
- Myopathies
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 Proprioceptive Neuromuscular Facilitation (contract-relax) technique with EMS | Other | experimental group |
| control groupPatients will receive conventional therapy. | Other | control group |
Primary outcome
Modified Barthel Index:
Time frame: 9 months
It is used for assessing the activities of daily living. It is composed of 10 questions that link the degree of independence to daily living activities. Collin et, al; proposed amendment in 1988, in which each domain was scored in one-point increments, ranging from 0 to 2 or 3 for each activity with a maximum score of 20 suggesting functional independence. It is highly reliable and has a good correlation with other disability measures.
Modified Ashworth Scale:
Time frame: 9 months
Modified Ashworth Scale: It is used to assess the spasticity in patients of stroke or spinal cord injury. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity. It is characterized by exaggerated deep tendon reflexes that interfere with muscular activity, gait, movement, or speech. It has excellent validity and reliability.
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 27 Oct 2023.
- Background: PubMed 25104481Hankey GJ. The global and regional burden of stroke. Lancet Glob Health. 2013 Nov;1(5):e239-40. doi: 10.1016/S2214-109X(13)70095-0. Epub 2013 Oct 24. No abstract available.
- Background: PubMed 8291967Faghri PD, Rodgers MM, Glaser RM, Bors JG, Ho C, Akuthota P. The effects of functional electrical stimulation on shoulder subluxation, arm function recovery, and shoulder pain in hemiplegic stroke patients. Arch Phys Med Rehabil. 1994 Jan;75(1):73-9.
- Background: PubMed 24377757Rong W, Tong KY, Hu XL, Ho SK. Effects of electromyography-driven robot-aided hand training with neuromuscular electrical stimulation on hand control performance after chronic stroke. Disabil Rehabil Assist Technol. 2015 Mar;10(2):149-59. doi: 10.3109/17483107.2013.873491. Epub 2013 Dec 31.
- 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 experimental group 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 3 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: finished, as of the sponsor's last update on 27 Oct 2023. 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?
Modified Barthel Index: (time frame: 9 months). The study lists 2 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 NCT05916872, 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 27 Oct 2023.