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MRP and PNF Effect on Upper Limb Motor Performance and Quality of Life in Sub-acute Stroke

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Motor Relearning Program
Proprioceptive Neuromuscular Facilitation
Conventional Physical Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • PSRD, Ittefaq Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Motor Relearning Program

Proprioceptive Neuromuscular Facilitation

Conventional Physical Therapy

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Modified Ashworth Scale (MAS)
It is used to assess spasticity. its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension the point at which the first soft resistance is met. Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion.
Motor Assessment Scale
The MAS was originally designed to assess eight subsets of motor function and one subset of muscle tone. The upper limb subscale (UL-MAS) consists of subset 6: 'Upper Arm Activity', subset 7: 'Hand Movements', and subset 'Advanced Hand Activities'.
Stroke Impact Scale
It is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional Stroke outcomes, including strength, hand function Activities of Daily Living/ Instrumental Activities of Daily Living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation.

Full Information

First Posted
June 20, 2022
Last Updated
July 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05429944
Brief Title
MRP and PNF Effect on Upper Limb Motor Performance and Quality of Life in Sub-acute Stroke
Official Title
Comparative Effects of Motor Relearning Program and Proprioceptive Neuromuscular Facilitation on Upper Limb Motor Performance and Quality of Life in Sub-acute Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
One study revealed that both PNF and CIMT were effective in the management of upper limb chronic post- stroke patients. However, CIMT is the preferred technique for upper limb function recovery. Another experimental study was conducted on comparison between proprioceptive neuromuscular facilitation versus mirror therapy enhances gait and balance in paretic lower limb in acute stroke. In this study patients are randomly divided into two groups. According to statistical analysis this study shows that both the techniques Group A (Proprioceptive Neuromuscular Facilitation) and Group B (Mirror Therapy) were individually effective in improving gait and balance. While comparing both the techniques there is a significant difference present in the group. So, Group A is more effective in enhancing gait and balance in paretic lower limb after acute Stroke. Another randomized control trial was conducted on comparing the effects of motor relearning programs and mirror therapy for improving upper limb motor function in stroke patient. This study concluded that MRP and MT were found to be effective in improving upper limb motor function of stroke patients, but the former was more effective than the later. Another comparative study was conducted on motor relearning program versus proprioceptive neuro-muscular facilitation technique for improving basic mobility in chronic stroke patients- According to the results he concluded that MRP is more effective then PNF for improving basic mobility of sit to stand and walking in chronic stroke subjects and subjects were able to maintain their basic mobility at one month follow up also. Previous studies have compared only a single intervention with controls; however, this study aims to compare two different interventions in addition to comparison with the control groups. All these interventions previously used focus on the functional activities as a training component after stroke and have shown some degree of improvement in the functional outcome of the upper limb, but still, there is a paucity of literature on which intervention improves motor performance in an optimum timeframe during the subacute phase of stroke. Given this gap in the literature, a study is needed to elucidate the comparative effects of motor relearning program and proprioceptive neuromuscular facilitation on upper limb motor performance and quality of life in sub-acute stroke survivors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Relearning Program
Arm Type
Experimental
Arm Description
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
Arm Title
Proprioceptive Neuromuscular Facilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Physical Therapy
Arm Type
Active Comparator
Arm Description
Electrotherapy includes TENS, Electrical stimulation and Heat therapy. ROM . Stretching and positioning Exercises Strengthening Exercises for the weak muscles. Sensory Interventions.
Intervention Type
Other
Intervention Name(s)
Motor Relearning Program
Intervention Description
The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
Description
It is used to assess spasticity. its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension the point at which the first soft resistance is met. Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion.
Time Frame
6 weeks
Title
Motor Assessment Scale
Description
The MAS was originally designed to assess eight subsets of motor function and one subset of muscle tone. The upper limb subscale (UL-MAS) consists of subset 6: 'Upper Arm Activity', subset 7: 'Hand Movements', and subset 'Advanced Hand Activities'.
Time Frame
6 weeks
Title
Stroke Impact Scale
Description
It is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional Stroke outcomes, including strength, hand function Activities of Daily Living/ Instrumental Activities of Daily Living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Recurrent Stroke Patients with other neurological conditions and deficits. Patients with other orthopedic condition like frozen shoulder or unhealed fracture of upper limb.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Aabroo, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PSRD, Ittefaq Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54600, 54700
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29233831
Citation
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.
Results Reference
background
PubMed Identifier
33235584
Citation
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.
Results Reference
background
PubMed Identifier
26649007
Citation
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.
Results Reference
background
PubMed Identifier
31511706
Citation
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.
Results Reference
background
PubMed Identifier
31017023
Citation
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.
Results Reference
background
PubMed Identifier
30972016
Citation
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.
Results Reference
background
PubMed Identifier
27964964
Citation
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.
Results Reference
background
PubMed Identifier
20854586
Citation
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.
Results Reference
background

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MRP and PNF Effect on Upper Limb Motor Performance and Quality of Life in Sub-acute Stroke

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