NCT05429944

Brief Summary

Through this study we compare the the effects of motor relearning program and proprioceptive neuromuscular facilitation on upper limb motor performance and quality of life in sub-acute stroke survivors. This study will be a randomized controlled trial will recruit a sample of 39 participants through non-probability consecutive sampling technique. After satisfying the inclusion criteria, participants will be divided into three groups. The first group will receive motor relearning program for 6 weeks, 3 times per week for 30 minutes, along with the conventional therapy. The second group will receive proprioceptive neuromuscular facilitation for 6 weeks, 3 times per week for 30 minutes, along with conventional therapy. The third group will only receive conventional the conventional therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

June 20, 2022

Last Update Submit

July 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment Upper Extremity (FMA-UE)

    Changes from baseline The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. Each item consists of a 3- point scale (0, 1, and 2), with a total maximum score of 66.

    6 weeks

Secondary Outcomes (3)

  • Modified Ashworth Scale (MAS)

    6 weeks

  • Motor Assessment Scale

    6 weeks

  • Stroke Impact Scale

    6 weeks

Study Arms (3)

Motor Relearning Program

EXPERIMENTAL

MRP is a task- oriented approach to improve motor control, focusing on relearning of daily activities. Based on 4 steps 1.Analysis of task 2.Practice of missing component 3.Practice of task 4.Transference of learning

Other: Motor Relearning Program

Proprioceptive Neuromuscular Facilitation

EXPERIMENTAL

Proprioceptive Neuromuscular Facilitation (PNF) is the neurophysiological approach in which impulses from the periphery are facilitated to the central nervous system through the stimulation of sensory receptors present in muscles and around the joints by stretch, resistance, traction, approximation and audiovisual command to the patient. The techniques administered included Rhythmic Initiation, Slow Reversal and Agonistic Reversal.

Other: Proprioceptive Neuromuscular Facilitation

Conventional Physical Therapy

ACTIVE COMPARATOR

Electrotherapy includes TENS, Electrical stimulation and Heat therapy. ROM . Stretching and positioning Exercises Strengthening Exercises for the weak muscles. Sensory Interventions.

Other: Conventional Physical Therapy

Interventions

The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.

Motor Relearning Program

The techniques administered included Rhythmic Initiation, Slow Reversal and Agonistic Reversal. The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.

Proprioceptive Neuromuscular Facilitation

The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.

Conventional Physical Therapy

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40-70 years are included.
  • Both genders are included
  • Hemiplegic ischemic stroke of both sides
  • Participants with sub-acute Stroke (from 1 week to 6 months).
  • Non- aphasic stroke patients.
  • Clinically stable patients.

You may not qualify if:

  • Recurrent Stroke
  • Patients with other neurological conditions and deficits.
  • Patients with other orthopedic condition like frozen shoulder or unhealed fracture of upper limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSRD, Ittefaq Hospital

Lahore, Punjab Province, 54600, 54700, Pakistan

Location

Related Publications (8)

  • Guiu-Tula FX, Cabanas-Valdes R, Sitja-Rabert M, Urrutia G, Gomara-Toldra N. The Efficacy of the proprioceptive neuromuscular facilitation (PNF) approach in stroke rehabilitation to improve basic activities of daily living and quality of life: a systematic review and meta-analysis protocol. BMJ Open. 2017 Dec 12;7(12):e016739. doi: 10.1136/bmjopen-2017-016739.

    PMID: 29233831BACKGROUND
  • Ullah I, Arsh A, Zahir A, Jan S. Motor relearning program along with electrical stimulation for improving upper limb function in stroke patients: A quasi experimental study. Pak J Med Sci. 2020 Nov-Dec;36(7):1613-1617. doi: 10.12669/pjms.36.7.2351.

    PMID: 33235584BACKGROUND
  • Batool S, Soomro N, Amjad F, Fauz R. To compare the effectiveness of constraint induced movement therapy versus motor relearning programme to improve motor function of hemiplegic upper extremity after stroke. Pak J Med Sci. 2015 Sep-Oct;31(5):1167-71. doi: 10.12669/pjms.315.7910.

    PMID: 26649007BACKGROUND
  • Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245.

    PMID: 31511706BACKGROUND
  • Diaz-Arribas MJ, Martin-Casas P, Cano-de-la-Cuerda R, Plaza-Manzano G. Effectiveness of the Bobath concept in the treatment of stroke: a systematic review. Disabil Rehabil. 2020 Jun;42(12):1636-1649. doi: 10.1080/09638288.2019.1590865. Epub 2019 Apr 24.

    PMID: 31017023BACKGROUND
  • Bai Z, Zhang J, Zhang Z, Shu T, Niu W. Comparison Between Movement-Based and Task-Based Mirror Therapies on Improving Upper Limb Functions in Patients With Stroke: A Pilot Randomized Controlled Trial. Front Neurol. 2019 Mar 26;10:288. doi: 10.3389/fneur.2019.00288. eCollection 2019.

    PMID: 30972016BACKGROUND
  • Singer B, Garcia-Vega J. The Fugl-Meyer Upper Extremity Scale. J Physiother. 2017 Jan;63(1):53. doi: 10.1016/j.jphys.2016.08.010. Epub 2016 Oct 17. No abstract available.

    PMID: 27964964BACKGROUND
  • Pickering RL, Hubbard IJ, Baker KG, Parsons MW. Assessment of the upper limb in acute stroke: the validity of hierarchal scoring for the Motor Assessment Scale. Aust Occup Ther J. 2010 Jun;57(3):174-82. doi: 10.1111/j.1440-1630.2009.00810.x.

    PMID: 20854586BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sara Aabroo, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Blinded (or "masked") studies are those in which the subjects, and possibly the investigators as well, are unaware of which treatment the subject is receiving, e.g., active drug or placebo. Blinding is particularly important in drug trials when the study is assessing subjective outcomes, such as relief of pain or anxiety. It isn't always possible to mask the treatments. For example, subjects randomly assigned to follow either a specific exercise regimen or continue their usual level of activity cannot be blinded. Single-blinded: the subjects are unaware of which group they have been assigned to. Double-blinded: Neither the subjects nor the investigators are aware of the treatment assignment until the end of the trial.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 23, 2022

Study Start

June 15, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations