Upper Extremity ParesisNCT05904795
PNF Strengthening and De-lorme and Watkins Exercises on Upper Extremity Function and Strength in Stroke Patients
A study testing PNF strengthening exercises and de-lorme and watkins exercises in people with Upper Extremity Paresis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to evaluate the effects of proprioceptive neuromuscular facilitation strengthening exercises and de-Lorme and Watkins exercises program in stroke patients with upper limb weakness in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Extremity Paresis
- What is being tested?
- PNF strengthening exercises and de-lorme and watkins exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2023to 30 Oct 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic stroke patients.
- Medically stable patients having a single stroke.
- History of stroke 6 to 24 months.
- A score greater than 24-30 in mini-mental test.
- Patients having consciousness with GC;10
Who cannot join
- Recurrent stroke
- Patients with gullian berrie syndrome, multiple sclerosis lesion osteoarthritis of shoulder.
- Manual muscle testing below grade II.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shahida Islam teaching hospital Lodhran
Lodhran, Punjab Province, 47541
Hira Jabeen, MSNMPT, +92-323-4116506, hirajabeen@riphah.edu.pk
Zainab Tehreem, MSNMPT
About this study
Official title: Comparative Effects of Proprioceptive Neuromuscular Facilitation Strengthening Exercises and De-lorme and Watkins Exercises Program on Upper Limb Function and Strength in Chronic Stroke Patients
The aim of this study is to evaluate the effects of proprioceptive neuromuscular facilitation strengthening exercises and de-Lorme and Watkins exercises program in stroke patients with upper limb weakness in chronic stroke patients. The randomized central trial will recruit patients according to consecutive sampling into two intervention groups. One group will receive proprioceptive neuromuscular facilitation strengthening exercises and other group will receive de-Lorme and Watkins exercises program.
Read the detailed description
A study in which the participants (n=26) were recruited in the study suffering from stroke and meeting the inclusion criteria. Two groups formed such that patients in group A will be treated with conventional therapy and PNF and group B will be treated with PNF and NMES in along with conventional therapy. The protocol will cover 6 weeks of treatment. Regular assessment at 0,3rd and 6th week will be carried out. In the rehabilitation period, we will evaluate upper extremity function, activities of daily living(ADLs), mental status examination at regular interval during the rehabilitation.In previous studies there is less literature regarding the combine effects of proprioceptive neuromuscular facilitation techniques and de-Lorme and Watkins exercise program on upper limb function and strength in chronic stroke patients with upper limb weakness. Therefore there is dire need to explore which training technique is most effective in improving upper limb function and strength in chronic stroke patients therefore this study aims in comparative effects of proprioceptive neuromuscular facilitation strengthening exercises and de-Lorme and Watkins exercise program on upper limb function and strength in chronic stroke patients.
- Conditions
- Upper Extremity Paresis
- Being tested
- PNF strengthening exercises, de-lorme and watkins exercises
- Keywords
- Proprioceptive neuromuscular facilitation
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF strengthening exercisesOther
PNF strengthening exercises 10 repetitions, 1set , 4 days/week along with range of motion exercises total of 4 sessions were given consisting 40 minutes
de-lorme and watkins exercisesOther
The group was given de-lorme and watkins progressive resistance exercises along with range of motion exercises .10 repetitions, 1set, 4 days /week along with range of motion exercises.
total of 4 sessions per week each consisting of 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PNF strengthening exercises | Active comparator | Pnf strengthening exercises along with isometrics and range of motion exercises Receives: Other: PNF strengthening exercises |
| de-lorme and watkins progressive resistance exercises | Active comparator | progressive resistance exercises along with isometrics and range of motion exercises Receives: Other: de-lorme and watkins exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The barthel index scale
The Barthel Index (BI) is a measure of independence in activities of daily living (ADL).It contains 10 components which has different scores.The total score is calculated by dividing 100.
Measured: 4th day
Hand held dynamometer
The hand held dynamometry is an objective method in detecting minimum muscle strength change, which has an impact on the physical function of ICU survivors. The minimum change in the fore can be measured in units of weight such as pounds or kilograms.
Measured: 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start25 Feb 2023
- Primary completion18 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity ParesisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira Jabeen, MSNMPT, Principal investigator, Riphah International Universiry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904795
- Sponsor's protocol ID
- REC/LHR/23/0215 ZAINAB TEHREEM
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrade SE, Harrold LR, Tjia J, Cutrona SL, Saczynski JS, Dodd KS, Goldberg RJ, Gurwitz JH. A systematic review of validated methods for identifying cerebrovascular accident or transient ischemic attack using administrative data. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1(Suppl 1):100-28. doi: 10.1002/pds.2312.
PubMed 22262598Zuber M, Mas JL. [Epidemiology of cerebrovascular accidents]. Rev Neurol (Paris). 1992;148(4):243-55. French.
PubMed 1439451Gillespie CD, Wigington C, Hong Y; Centers for Disease Control and Prevention (CDC). Coronary heart disease and stroke deaths - United States, 2009. MMWR Suppl. 2013 Nov 22;62(3):157-60.
PubMed 24264507Mergenthaler P, Dirnagl U, Meisel A. Pathophysiology of stroke: lessons from animal models. Metab Brain Dis. 2004 Dec;19(3-4):151-67. doi: 10.1023/b:mebr.0000043966.46964.e6.
PubMed 15554412Harris JE, Eng JJ. Paretic upper-limb strength best explains arm activity in people with stroke. Phys Ther. 2007 Jan;87(1):88-97. doi: 10.2522/ptj.20060065. Epub 2006 Dec 19.
PubMed 17179441Hendricks HT, van Limbeek J, Geurts AC, Zwarts MJ. Motor recovery after stroke: a systematic review of the literature. Arch Phys Med Rehabil. 2002 Nov;83(11):1629-37. doi: 10.1053/apmr.2002.35473.
PubMed 12422337Pak S, Patten C. Strengthening to promote functional recovery poststroke: an evidence-based review. Top Stroke Rehabil. 2008 May-Jun;15(3):177-99. doi: 10.1310/tsr1503-177.
PubMed 18647724
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Proprioceptive Neuromuscular Facilitation Strengthening Exercises and De-lorme and Watkins Exercises Program on Upper Limb Function and Strength in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05904795
- Acronym / sponsor ID
- REC/LHR/23/0215 ZAINAB TEHREEM
- Conditions
- Upper Extremity Paresis
- Keywords
- Proprioceptive neuromuscular facilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 18 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 15 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.
The aim of this study is to evaluate the effects of proprioceptive neuromuscular facilitation strengthening exercises and de-Lorme and Watkins exercises program in stroke patients with upper limb weakness in chronic stroke patients. The randomized central trial will recruit patients according to consecutive sampling into two intervention groups. One group will receive proprioceptive neuromuscular facilitation strengthening exercises and other group will receive de-Lorme and Watkins exercises program.
Detailed description
A study in which the participants (n=26) were recruited in the study suffering from stroke and meeting the inclusion criteria. Two groups formed such that patients in group A will be treated with conventional therapy and PNF and group B will be treated with PNF and NMES in along with conventional therapy. The protocol will cover 6 weeks of treatment. Regular assessment at 0,3rd and 6th week will be carried out. In the rehabilitation period, we will evaluate upper extremity function, activities of daily living(ADLs), mental status examination at regular interval during the rehabilitation.In previous studies there is less literature regarding the combine effects of proprioceptive neuromuscular facilitation techniques and de-Lorme and Watkins exercise program on upper limb function and strength in chronic stroke patients with upper limb weakness. Therefore there is dire need to explore which training technique is most effective in improving upper limb function and strength in chronic stroke patients therefore this study aims in comparative effects of proprioceptive neuromuscular facilitation strengthening exercises and de-Lorme and Watkins exercise program on upper limb function and strength in chronic stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF strengthening exercises | Active comparator | Other: PNF strengthening exercisesPnf strengthening exercises along with isometrics and range of motion exercises |
| de-lorme and watkins progressive resistance exercises | Active comparator | Other: de-lorme and watkins exercisesprogressive resistance exercises along with isometrics and range of motion exercises |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic stroke patients.
- Medically stable patients having a single stroke.
- History of stroke 6 to 24 months.
- A score greater than 24-30 in mini-mental test.
- Patients having consciousness with GC;10
Key exclusion criteria (3 listed)
- Recurrent stroke
- Patients with gullian berrie syndrome, multiple sclerosis lesion osteoarthritis of shoulder.
- Manual muscle testing below grade II.
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 |
|---|---|---|
| PNF strengthening exercisesPNF strengthening exercises 10 repetitions, 1set , 4 days/week along with range of motion exercises total of 4 sessions were given consisting 40 minutes | Other | PNF strengthening exercises |
| de-lorme and watkins exercisesThe group was given de-lorme and watkins progressive resistance exercises along with range of motion exercises .10 repetitions, 1set, 4 days /week along with range of motion exercises. total of 4 sessions per week each consisting of 40 minutes. | Other | de-lorme and watkins progressive resistance exercises |
Primary outcome
The barthel index scale
Time frame: 4th day
The Barthel Index (BI) is a measure of independence in activities of daily living (ADL).It contains 10 components which has different scores.The total score is calculated by dividing 100.
Hand held dynamometer
Time frame: 4th day
The hand held dynamometry is an objective method in detecting minimum muscle strength change, which has an impact on the physical function of ICU survivors. The minimum change in the fore can be measured in units of weight such as pounds or kilograms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 22262598Andrade SE, Harrold LR, Tjia J, Cutrona SL, Saczynski JS, Dodd KS, Goldberg RJ, Gurwitz JH. A systematic review of validated methods for identifying cerebrovascular accident or transient ischemic attack using administrative data. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1(Suppl 1):100-28. doi: 10.1002/pds.2312.
- Background: PubMed 1439451Zuber M, Mas JL. [Epidemiology of cerebrovascular accidents]. Rev Neurol (Paris). 1992;148(4):243-55. French.
- Background: PubMed 24264507Gillespie CD, Wigington C, Hong Y; Centers for Disease Control and Prevention (CDC). Coronary heart disease and stroke deaths - United States, 2009. MMWR Suppl. 2013 Nov 22;62(3):157-60.
- Background: PubMed 15554412Mergenthaler P, Dirnagl U, Meisel A. Pathophysiology of stroke: lessons from animal models. Metab Brain Dis. 2004 Dec;19(3-4):151-67. doi: 10.1023/b:mebr.0000043966.46964.e6.
- Background: PubMed 17179441Harris JE, Eng JJ. Paretic upper-limb strength best explains arm activity in people with stroke. Phys Ther. 2007 Jan;87(1):88-97. doi: 10.2522/ptj.20060065. Epub 2006 Dec 19.
- Background: PubMed 12422337Hendricks HT, van Limbeek J, Geurts AC, Zwarts MJ. Motor recovery after stroke: a systematic review of the literature. Arch Phys Med Rehabil. 2002 Nov;83(11):1629-37. doi: 10.1053/apmr.2002.35473.
- Background: PubMed 18647724Pak S, Patten C. Strengthening to promote functional recovery poststroke: an evidence-based review. Top Stroke Rehabil. 2008 May-Jun;15(3):177-99. doi: 10.1310/tsr1503-177.
- 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.
Hira Jabeen, MSNMPT principal investigator
Riphah International Universiry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF strengthening exercises and de-lorme and watkins exercises in people with Upper Extremity Paresis, 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hira Jabeen, MSNMPT (03234116506, hirajabeen@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The barthel index scale (time frame: 4th day). 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 NCT05904795, which also lists 7 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 15 Jun 2023.