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Completed

NCT Number: NCT05916872

Combined Effects of PNF 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.

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Key information

Conditions

Stroke Balance; Distorted Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Proprioceptive Disorders Sensation Disorders Signs and Symptoms Somatosensory Disorders Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Islamabad, Fedral, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both ischemic and haemorrhagic stroke patients
  • Chronic stroke patients from 6 month to 2years
  • Mini Mental Scale Examination (MMSE) more than 25

Exclusion criteria

  • Transient ischemic attack
  • Recurrent stroke
  • Stroke patient with comorbidity and cardiac disease
  • Myopathies

Treatment and study plan

experimental group

Other

Patients will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique with EMS

Control Group

Other

Patients will receive conventional therapy.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Proprioceptive Neuromuscular Facilitation and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2023
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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