NCT05812638

Brief Summary

Stroke is a neurological impairment occurs due to cardiovascular abnormality and cerebrovascular disease. The term 'stroke' is mostly used when there is sudden loss of function of the body due any abrupt changes.The rates of disability are increasing along with mortality and morbidity rates due to stroke. The poor motor performance of lower limb affects gait severely. The slow velocity and other gait deviations limit the stroke survivors' ability to perform ADL's and interfere with their quality of life. Hence, rehabilitation is obligatory for these patients to improve their quality of life

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

April 13, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

March 31, 2023

Last Update Submit

March 31, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Fugl Meyer Assessment Scale - Lower Extremity

    This scale is recognized as a golden standard for assessment of motor function of stroke patients worldwide. It focuses on reflex activity, voluntary movements within and outside of synergies, ability to perform isolated movement, and coordination

    week 6

  • Berg Balance Scale

    In elderly Population, BBS is most commonly used outcome measure for functional balance. It is 14 Item balance measure scored on 5-point ordinal scale with range of 0 to 4, where high score indicates good balance \& decreased risk of fall and vice versa. A maximum score of 56 is achievable

    week 6

  • Timed Up and Go test

    It is used to assess functional mobility; the risk of fall and dynamic balance can also be determined. In TUG test, the participant is asked to get up from a chair, walk a distance of 3 meters at Regular pace, turn around, walk a distance of 3 meter back to the chair and sit down

    week 6

  • 10-meter walk test

    In this test, the participant walks through a 10-m walkway without any break. At the 4- m of walkway, time is recorded in order to obtain a rhythmic phase of walking speed

    week 6

  • Wisconsin Gait Scale

    This scale is used to assess gait cycle. It consists of 14 items, the higher the score, greater will be the disability. These scale focuses on the components of stance phase, guardedness of affected leg, toe off, swing phase and heel strike

    week 6

Study Arms (2)

Mental Imagery

EXPERIMENTAL

For mental imagery, the calm and nice atmosphere isrequired for the patientsto focus on the details while sitting on a chair. The audiotape and headphones are given to the patients. The audiotape tape comprised of three phases. The first phase is relaxation phase. The patient has to do the first phase actively. In this phase patients have asked to do the deep breathing exercises while sitting on a chair and then contract their lower limb muscles from distal to proximal. The second phase is task-oriented phase. The patient has to imagine him performing the tasks.

Other: Mental imagery technique

Virtual Reality

ACTIVE COMPARATOR

The virtual reality training will be given through Kinect connected with Xbox 360. The Xbox games used are 20,000 water leaks, reflex ridge and river rush. The spacious environment will be given and walker are sometimes required for assistance. The LED and system are 3 feet away from patients. The VR training will be given to the both control and experimental groups

Other: Virtual Reality technique

Interventions

Warm up Period Mental Imagery (Sit-stand task Static stance (30 seconds) Indoor walk on a leveled surface Walk indoor towards target Forward / Side Stepping) Walk outdoors

Mental Imagery

Virtual reality training (River rush, 20000 water leaks, reflex ridge.)

Virtual Reality

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Stroke patients (both genders)
  • Age 40-60 years
  • Patients with sub-acute/ chronic stroke (\>3 months)
  • Modified Ashworth Ranking Scale 1-3
  • MOCA scoring \>24-30

You may not qualify if:

  • Any active pathological condition
  • Visual or hearing impairment
  • Orthopedic issues hindering Mobility Substantially (Fractures, Severe Degenerative
  • Joint Diseases etc.)
  • Psychological issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • arshad Malik, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 13, 2023

Study Start

March 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

April 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations