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Effects of Joint Integrity Exercises Verses Mirror Therapy in Hemineglect Stroke Survivors

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Joint integrity exercises
Mirror therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Joint integrity ,Proprioception, Mirror therapy, Hemineglect

Eligibility Criteria

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

Inclusion Criteria:

  • Hemi neglect stroke patients after performing line bisection test
  • Patients having Mini mental State Examination score above 24
  • Patients having Catherine Bergego scale score above 27
  • Patients having minimum MIQ-3 score 6 or above
  • Sub-acute phase (2 Months) following stroke

Exclusion Criteria:

  • Patients with neurological conditions other than stroke including Parkinson's, Alzheimer and Multiple sclerosis

Sites / Locations

  • Lahore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Joint integrity exercises

Mirror therapy

Arm Description

Tactile stimulation with the various textures will be applied to the patients with three strokes followed by 3 sec rest period. Kinaesthetic stimulations will be given to the patients to increase proprioception proprioception in neglected limb in sitting position, the limb on the affected side of the body is supported and moved by the examiner in various directions but movement is only at one joint at a time. Stereognosis by placing the object in the patient's hand for a maximum 30 seconds with close eyes. Identification is by naming, description or by pair matching with an identical set.

A 5 cm × 35 cm mirror will be placed vertically between the upper limbs on the table, with the reflecting surface facing the uninjured limb. Patients will be asked to observe the motion of the upper limb on the uninjured side and imagine that the limb on the affected side was in motion, imagine the motion of the affected limb the same as that observed on the uninjured side, and complete 6 movements including shoulder joint forward flexion, elbow joint flexion and extension, forearm forward and backward rotation, wrist joint flexion and extension, finger extension and grasping, and thumb abduction. The participants will be asked to perform each movement for 5 min and try to reach the maximum range of motion of the joints. Training will be completed for 30 min per day) Session will be 3 days per week. Per day session will be for 30 minutes.

Outcomes

Primary Outcome Measures

Fugl-Meyer Upper Extremity Assessment
The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is used for assessment of motor function of upper extremity. The FMUE Scale comprises 33 items, each item scored on 3 point ordinal scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. Total score for motor function is 66. Reading will be at Baseline and after 4 weeks
Nottingham sensory assessment
NSA is used in clinical trials in stroke patients to test effectiveness of different interventions. It is used for sensory examination of tactile sensation, kinesthesia and stereognosis. Tactile scoring is 0-2, where 0 = absent, 1 = impaired and 2 = normal. Stereognosis scoring is 0-2, where 0 = absent, 1 = impaired and 2 = normal. Kinesthesia scoring 0-3, where 0 = absent, 1 = appreciation of movement taking place, 2 = direction of movement sense and 3 = joint position sense. Reading will be at Baseline and after 4 weeks
Motor assessment scale
This scale is designed to assess the return of function following a stroke or other neurological impairment. The test looks at a patient's ability to move with low tone or in a synergistic pattern and finally move actively out of that pattern into normal movement. It consists of 9 sections. The higher the score, the higher functioning the patient has on the affected side. High Score = 54 and Low Score = 0. Reading will be at Baseline and after 4 weeks

Secondary Outcome Measures

Full Information

First Posted
May 31, 2022
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05404971
Brief Title
Effects of Joint Integrity Exercises Verses Mirror Therapy in Hemineglect Stroke Survivors
Official Title
Effects of Joint Integrity Exercises Verses Mirror Therapy on Proprioception and Functional Rehabilitation of Upper Limb in Hemineglect Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 30, 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
No

5. Study Description

Brief Summary
The aim of this study is to compare the effects of joint integrity exercises and mirror therapy to evaluate that which intervention is more effective to improve proprioception and motor function of upper limb in hemineglect stroke survivors. This will be randomized clinical triall study. Data will be collected from Lahore General Hospital by using non-probability convenient sampling technique. Patients will be divided into two groups, (Group A and Group B). Group A will include patients that will be treated with joint integrity exercises of upper limb by applying tactile stimulation, kinaesthetic stimulation and stereognosis. and Group B will include those patients which will be treated with mirror therapy of upper limb. Session will be 3 days per week. Data will be collected pre (baseline=0 week) and post intervention (after 6 weeks) from two groups using Nottingham sensory assessment, Fugl Mayer Assessment and Motor assessment scale. SPSS for windows software, version 25 will be used to analyze the data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Joint integrity ,Proprioception, Mirror therapy, Hemineglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Joint integrity exercises
Arm Type
Experimental
Arm Description
Tactile stimulation with the various textures will be applied to the patients with three strokes followed by 3 sec rest period. Kinaesthetic stimulations will be given to the patients to increase proprioception proprioception in neglected limb in sitting position, the limb on the affected side of the body is supported and moved by the examiner in various directions but movement is only at one joint at a time. Stereognosis by placing the object in the patient's hand for a maximum 30 seconds with close eyes. Identification is by naming, description or by pair matching with an identical set.
Arm Title
Mirror therapy
Arm Type
Active Comparator
Arm Description
A 5 cm × 35 cm mirror will be placed vertically between the upper limbs on the table, with the reflecting surface facing the uninjured limb. Patients will be asked to observe the motion of the upper limb on the uninjured side and imagine that the limb on the affected side was in motion, imagine the motion of the affected limb the same as that observed on the uninjured side, and complete 6 movements including shoulder joint forward flexion, elbow joint flexion and extension, forearm forward and backward rotation, wrist joint flexion and extension, finger extension and grasping, and thumb abduction. The participants will be asked to perform each movement for 5 min and try to reach the maximum range of motion of the joints. Training will be completed for 30 min per day) Session will be 3 days per week. Per day session will be for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Joint integrity exercises
Intervention Description
patients with three strokes followed by 3 sec rest period. Kinaesthetic stimulations will be given to the patients to increase proprioception proprioception in neglected limb in sitting position, the limb on the affected side of the body is supported and moved by the examiner in various directions but movement is only at one joint at a time. Stereognosis by placing the object in the patient's hand for a maximum 30 seconds with close eyes. Identification is by naming, description or by pair matching with an identical set.
Intervention Type
Other
Intervention Name(s)
Mirror therapy
Intervention Description
A 5 cm × 35 cm mirror will be placed vertically between the upper limbs on the table, with the reflecting surface facing the uninjured limb. Patients will be asked to observe the motion of the upper limb on the uninjured side and imagine that the limb on the affected side was in motion, imagine the motion of the affected limb the same as that observed on the uninjured side, and complete 6 movements including shoulder joint forward flexion, elbow joint flexion and extension, forearm forward and backward rotation, wrist joint flexion and extension, finger extension and grasping, and thumb abduction. The participants will be asked to perform each movement for 5 min and try to reach the maximum range of motion of the joints. Training will be completed for 30 min per day) Session will be 3 days per week. Per day session will be for 30 minutes.
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity Assessment
Description
The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is used for assessment of motor function of upper extremity. The FMUE Scale comprises 33 items, each item scored on 3 point ordinal scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. Total score for motor function is 66. Reading will be at Baseline and after 4 weeks
Time Frame
4 weeks
Title
Nottingham sensory assessment
Description
NSA is used in clinical trials in stroke patients to test effectiveness of different interventions. It is used for sensory examination of tactile sensation, kinesthesia and stereognosis. Tactile scoring is 0-2, where 0 = absent, 1 = impaired and 2 = normal. Stereognosis scoring is 0-2, where 0 = absent, 1 = impaired and 2 = normal. Kinesthesia scoring 0-3, where 0 = absent, 1 = appreciation of movement taking place, 2 = direction of movement sense and 3 = joint position sense. Reading will be at Baseline and after 4 weeks
Time Frame
4 weeks
Title
Motor assessment scale
Description
This scale is designed to assess the return of function following a stroke or other neurological impairment. The test looks at a patient's ability to move with low tone or in a synergistic pattern and finally move actively out of that pattern into normal movement. It consists of 9 sections. The higher the score, the higher functioning the patient has on the affected side. High Score = 54 and Low Score = 0. Reading will be at Baseline and after 4 weeks
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemi neglect stroke patients after performing line bisection test Patients having Mini mental State Examination score above 24 Patients having Catherine Bergego scale score above 27 Patients having minimum MIQ-3 score 6 or above Sub-acute phase (2 Months) following stroke Exclusion Criteria: Patients with neurological conditions other than stroke including Parkinson's, Alzheimer and Multiple sclerosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tehreem Mukhtar, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahore General Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24505342
Citation
Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
Results Reference
background
PubMed Identifier
31601801
Citation
Campbell BCV, De Silva DA, Macleod MR, Coutts SB, Schwamm LH, Davis SM, Donnan GA. Ischaemic stroke. Nat Rev Dis Primers. 2019 Oct 10;5(1):70. doi: 10.1038/s41572-019-0118-8.
Results Reference
background
Citation
Harrison DH, DeVore BB, Campbell RW, Harrison PK. Hallucinations and hemispatial neglect following right middle cerebral artery cerebrovascular accident: Left gaze bias with left sensory hemineglect syndrome. 2017
Results Reference
background

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Effects of Joint Integrity Exercises Verses Mirror Therapy in Hemineglect Stroke Survivors

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