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Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Constrained induced movement
Proprioceptive Neuromuscular facilitation
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both male and female
  • Patients who will be diagnosed with hemiplegia due to stroke
  • Patient who has an asymmetrical stance, ability to walk and stand with minimal assistance
  • Patient must have 15 degrees of knee flexion in the affected limb
  • Mini mental state examination Mini Mental State Examination >23

Exclusion Criteria:

  • Patients who cannot perform the active movement of a limb due to pre stroke musculoskeletal problems
  • Cardiopulmonary diseases which could hinder their ability to take part in rehabilitation
  • Patient with impaired cognition

Sites / Locations

  • Helping Hand institute of Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Constrained induced movement therapy

Proprioceptive Neuromuscular facilitation therapy

Arm Description

In this group of patients, they will use the CIMT technique for treatment. Patient will perform following tasks, while unaffected limb in constrains for 3 hours/day Sit-to-Stand Forward and Backward stepping Stair Climbing and Descending (only the first stair will be used) Side-to-Side stepping with the affected limb

Different PNF components (such as commands, stretching, timing, and manual resistance) will be used for optimizing patients' output. We will do ten repetitions of each pattern before Proceeding to the next pattern. The PNF patterns in the set used in the study will be : Lower extremity: < Flexion-abduction-external rotation (knee flexed and knee extended) < Extension-adduction-internal rotation (knee flexed and knee extended) < Flexion-adduction-internal rotation (knee flexed and knee extended) < Extension-abduction-external rotation (knee flexed and knee extended

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment (FMA)
The FMA scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. They divided it into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
Timed up and go test
The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke. 10s Completely independent With or without walking aid for ambulation and transfers < 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone > 30s Requires assistance dependent in most activities
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2021
Last Updated
September 17, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05191524
Brief Title
Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function
Official Title
Comparison of Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
June 27, 2022 (Actual)
Study Completion Date
June 27, 2022 (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
Yes

5. Study Description

Brief Summary
Stroke, described as a neurological deficit caused by the interruption of cerebral blood flow, is one of the leading causes of mortality and morbidity throughout the world. It is the second most common medical condition and the major cause of disability in adults. Recovery following stroke revolves around the severity of sensory, motor, and cognitive impairments. Lower extremity impairment is one of the major post-stroke conditions which can cause difficulty in performing activities of daily living, gait abnormalities, increased risk of fall, and restriction in social participation. Rehabilitation after stroke is the primary mechanism through which it can achieve functional recovery and independence, which is based on the principles of motor learning and neuroplasticity.
Detailed Description
There have been many rehabilitation techniques to treat post-stroke impairments. These include aerobic exercises, the Bobath approach, proprioceptive neuromuscular facilitation (PNF) constraint-induced movement therapy (CIMT), and mobilization and stimulation of neuromuscular tissue. The selection of techniques at the defined level of recovery varies among clinicians. Constraint-induced movement therapy (CIMT) is a neurological rehabilitation technique that has been used in various neurological disorders including stroke both in acute and chronic stages, traumatic brain injury, cerebral palsy, multiple sclerosis, and spinal cord injury to improve motor function and strengthen weak muscles which are characterized by the restraint of the less affected extremity accompanied by the shaping and repetitive task-oriented training of more affected extremity. Proprioceptive facilitation (PNF) is one of the major therapeutic techniques aimed at enhancing the essential characteristics required for the functional ambulation of patients with hemiplegia, such as muscular control, strength, and flexibility. Changes in the excitation of the cortical motor area mediate this and the corresponding. Motor neurons. Previous researches are on the separate effect of CIMT and they have conducted PNF approaches, but there is no study available on the comparison of the effect of both techniques on lower limb function in stroke patients. Most of the studies administered PNF in combination with other approaches and the duration of intervention in these studies was in favor of CIMT groups compared to PNF. Therefore, this study is aimed at determining the comparative effect of CIMT and PNF on lower limb recovery.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Constrained induced movement therapy
Arm Type
Experimental
Arm Description
In this group of patients, they will use the CIMT technique for treatment. Patient will perform following tasks, while unaffected limb in constrains for 3 hours/day Sit-to-Stand Forward and Backward stepping Stair Climbing and Descending (only the first stair will be used) Side-to-Side stepping with the affected limb
Arm Title
Proprioceptive Neuromuscular facilitation therapy
Arm Type
Active Comparator
Arm Description
Different PNF components (such as commands, stretching, timing, and manual resistance) will be used for optimizing patients' output. We will do ten repetitions of each pattern before Proceeding to the next pattern. The PNF patterns in the set used in the study will be : Lower extremity: < Flexion-abduction-external rotation (knee flexed and knee extended) < Extension-adduction-internal rotation (knee flexed and knee extended) < Flexion-adduction-internal rotation (knee flexed and knee extended) < Extension-abduction-external rotation (knee flexed and knee extended
Intervention Type
Other
Intervention Name(s)
Constrained induced movement
Intervention Description
Practice in two sessions per day (supervised) for 3 days per week, for six consecutive weeks. The unaffected limb will be constraint using a knee immobilizer only during practice sessions. We will perform the interventions under the supervision of a trained physiotherapist.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular facilitation
Intervention Description
Group B will receive PNF intervention given for 30 minutes to the lower limb 3 times a week for 6 weeks
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA)
Description
The FMA scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. They divided it into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
Time Frame
week 6
Title
Timed up and go test
Description
The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke. 10s Completely independent With or without walking aid for ambulation and transfers < 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone > 30s Requires assistance dependent in most activities
Time Frame
week 6
Title
Berg Balance Scale
Description
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both male and female Patients who will be diagnosed with hemiplegia due to stroke Patient who has an asymmetrical stance, ability to walk and stand with minimal assistance Patient must have 15 degrees of knee flexion in the affected limb Mini mental state examination Mini Mental State Examination >23 Exclusion Criteria: Patients who cannot perform the active movement of a limb due to pre stroke musculoskeletal problems Cardiopulmonary diseases which could hinder their ability to take part in rehabilitation Patient with impaired cognition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Afridi, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helping Hand institute of Rehabilitation Sciences
City
Mansehra
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Çoban O. İnmeli hastalarda mekanik hippoterapi cihazı ile yapılan egzersizin postural kontrol ve denge üzerine etkisi. 2019
Results Reference
background
Citation
Abba M, Muhammad A, Badaru U, Abdullahi A. Comparative effect of constraint-induced movement therapy and proprioceptive neuromuscular facilitation on upper limb function of chronic stroke survivors. Physiotherapy Quarterly. 2020;28(1):1-5
Results Reference
background
PubMed Identifier
32873248
Citation
He L, Wang J, Wang F, Zhang L, Zhang L, Zhao W. Increased neutrophil-to-lymphocyte ratio predicts the development of post-stroke infections in patients with acute ischemic stroke. BMC Neurol. 2020 Sep 1;20(1):328. doi: 10.1186/s12883-020-01914-x.
Results Reference
background
PubMed Identifier
27621261
Citation
Randolph SA. Ischemic Stroke. Workplace Health Saf. 2016 Sep;64(9):444. doi: 10.1177/2165079916665400.
Results Reference
background
PubMed Identifier
32706202
Citation
Yu L, Tao J, Zhao Q, Xu C, Zhang Q. Confirmation of potential neuroprotective effects of natural bioactive compounds from traditional medicinal herbs in cerebral ischemia treatment. J Integr Neurosci. 2020 Jun 30;19(2):373-384. doi: 10.31083/j.jin.2020.02.63.
Results Reference
background
PubMed Identifier
19919699
Citation
Lakhan SE, Kirchgessner A, Hofer M. Inflammatory mechanisms in ischemic stroke: therapeutic approaches. J Transl Med. 2009 Nov 17;7:97. doi: 10.1186/1479-5876-7-97.
Results Reference
background
PubMed Identifier
28123618
Citation
Ojaghihaghighi S, Vahdati SS, Mikaeilpour A, Ramouz A. Comparison of neurological clinical manifestation in patients with hemorrhagic and ischemic stroke. World J Emerg Med. 2017;8(1):34-38. doi: 10.5847/wjem.j.1920-8642.2017.01.006.
Results Reference
background
PubMed Identifier
24595959
Citation
Chen S, Zeng L, Hu Z. Progressing haemorrhagic stroke: categories, causes, mechanisms and managements. J Neurol. 2014 Nov;261(11):2061-78. doi: 10.1007/s00415-014-7291-1. Epub 2014 Mar 5.
Results Reference
background
PubMed Identifier
28931491
Citation
GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.
Results Reference
background

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Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function

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