NCT04669431

Brief Summary

.To determine the effects of Xbox Kinect training on upper limb motor function with conventional physical therapy in stroke patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

December 9, 2020

Last Update Submit

December 9, 2020

Conditions

Keywords

Xbox Kinect TrainingUpper limbStroke

Outcome Measures

Primary Outcomes (5)

  • Modified Ashworth Scale

    Changes from the base line, Primary tools for measuring spasticity in post stroke patients, is Modified Ashworth Scale. Modified Ashworth Scale (MAS) is a measuring tool for spasticity consisting on total of 6 points. Marks ranges from zero to four, where 0 indicates normal muscle tone while higher numbers signifies high resistance.

    6th week

  • Montreal Cognitive Assessment

    Changes from the base line, The tool used for cognitive impairment is Montreal Cognitive Assessment (MoCA). As there is not at all, fairly effective measuring tool for the early diagnosis of cognitive impairments. MoCA is a successful screening test used for the screening of mild cognitive impairment. The MoCA test-retest intra-class relationship coefficient (ICC=0.79) and the inter-rater intra-class connection coefficient (ICC=0.81).The MoCA is a valid and reliable tool for cognitive assessment. Scores of MoCA ranges from 0-30.Interpretation of MoCA indicates that score of 26 and above normal, 18 -25 score indicates low cognitive impairments, 10 -18 score considered normal or moderate cognitive impairment while greater than 10 is considered to be severe cognitive impairments.

    6th week

  • Test Box and Block

    Changes from the Baseline, Test Box and block (BBT) measuring tool is used for the motor function of upper extremity. In the apparatus of this tool, there are two compartments of a box, and test is performed by picking up equal sized blocks from one compartment to another during 60 seconds. 15 seconds are provided to subjects for practice and then total numbers of blocks, transferred within 60 seconds are recorded.

    6th week

  • Wolf Motor Function Test

    Changes from the Baseline, Wolf Motor Function Test (WMFT) is considered as numerical catalogue for the assessment of upper extremity motor function. Motor skills of patients are assessed through time and well designed, practical and functional tasks.

    6th week

  • Fugl Meyer assessment of physical performance

    Changes from the Baseline, Fugl meyer assessment tool is used for the evaluation of recovery extent in post stroke patients. It consists of 226 total points and is divided in 5 major domains including sensory function, motor function, joint range of motion, balance and pain each domain contain multiple sub items. Scoring is being recorded on a 3-points ordinal scale where zero means unable to perform, one means partially performs and two means performs fully. Movement, coordination, reflex activity of shoulders, elbows, forearm, wrist and hand are included in motor domain. Normal motor performance starts from 0 to maximum 100 points and sub divided into 66 points for upper extremity.

    6th week

Study Arms (2)

Xbox kinect Training

EXPERIMENTAL

X Box Games include Tennis Playing, Joy riding, Rally ball.

Other: Xbox kinect Training

Conservative Rehabilitation

ACTIVE COMPARATOR

Sustained Stretching, repetitive task training, activities of daily living

Other: Conservative Rehabilitation

Interventions

Xbox kinect 360, Tennis player, Joy riding, Rally ball. Tennis player in first 2 weeks, Joy riding in 3rd and 4th weeks, and all 3 games in 5th and 6th weeks 35 minute/3 days a week for 6 weeks with Conventional physical therapy, 25 minute

Xbox kinect Training

Sustained Stretching, repetitive task training, activities of daily living( eating, grooming, folding of towel, basket lifting, turn key into lock, reaching forward, sideways reach, ball grasping, picking up small blocks and lifting cane and pencil) 35 minute/3 days a week for 6 weeks

Conservative Rehabilitation

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke\>6 months
  • No prior stroke
  • Modified Ashworth scale\<4
  • Patients able to follow instructions

You may not qualify if:

  • No previous deformity
  • Severe spastic hemiplegic
  • Patients with visual and cognitive impairment
  • Patients suffering from arm pain
  • Severe illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Amna Yaseen, MSPT(NMPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 16, 2020

Study Start

June 18, 2018

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations