PNF Strengthening and De-lorme and Watkins Exercises on Upper Extremity Function and Strength in Stroke Patients

June 6, 2023 updated by: Riphah International University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lodhran, Punjab, Pakistan, 47541
        • Recruiting
        • Shahida Islam teaching hospital Lodhran
        • Contact:
        • Principal Investigator:
          • Zainab Tehreem, MSNMPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Recurrent stroke
  • Patients with gullian berrie syndrome, multiple sclerosis lesion osteoarthritis of shoulder.
  • Manual muscle testing below grade II.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PNF strengthening exercises
Pnf strengthening exercises along with isometrics and range of motion exercises
Other: PNF strengthening exercises
PNF strengthening exercises 10 repetitions, 1set , 4 days/week along with range of motion exercises total of 4 sessions were given consisting 40 minutes
Active Comparator: de-lorme and watkins progressive resistance exercises
progressive resistance exercises along with isometrics and range of motion exercises
Other: de-lorme and watkins exercises

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4th day
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.
4th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hira Jabeen, MSNMPT, Riphah International Universiry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/LHR/23/0215 ZAINAB TEHREEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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