NCT05404971

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable stroke

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

May 5, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

May 31, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

Joint integrity ,Proprioception, Mirror therapy, Hemineglect

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    4 weeks

Study Arms (2)

Joint integrity exercises

EXPERIMENTAL

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.

Other: Joint integrity exercises

Mirror therapy

ACTIVE COMPARATOR

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.

Other: Mirror therapy

Interventions

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.

Joint integrity exercises

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.

Mirror therapy

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore General Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 24505342BACKGROUND
  • 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.

    PMID: 31601801BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Tehreem Mukhtar, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

May 5, 2022

Primary Completion

December 15, 2022

Study Completion

December 30, 2022

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations