NCT06844253

Brief Summary

This study is a randomized control trail and the purpose of this study is to determine the effects of exergaming versus task oriented training among sub-acute post-stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

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

July 10, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

November 14, 2024

Last Update Submit

February 19, 2025

Conditions

Keywords

ExergamingTask-oriented trainingTrunk controlsub-acute strokeTISBBS

Outcome Measures

Primary Outcomes (2)

  • TRUNK CONTROL

    It will be assessed by trunk impairment scale. for trunk control : trunk impairment scale has total scoring 0-16. 0= severe impairment, 16=no impairment. trunk impairment scale will measure the trunk control in static sitting and static standing. and in rotational movements in left and right direction.

    8 weeks

  • Balance

    assessed by berg balance scale for balance berg balance scale has total scoring 56. 0-20=severe impairment, 21-40=moderate impairment, 41-56=mild impairment. berg balance scale will measure the static and dynamic balance in both sitting and standing position.

    8 weeks

Study Arms (2)

Interventional Group

EXPERIMENTAL

The participants will receive intervention through exergaming XBOX 360 which includes Kinect 20,000 leaks, Kinect bubble pop and Kinect rally ball trunk exercises. week 1-2 Kinect bubble pop (beginner level), Kinect 20000 leaks (beginner level) week 3-4 Kinect bubble pop (intermediate level), Kinect 20000 leaks (intermediate level) week5-6 Kinect rally ball (beginner level), Kinect bubble pop (advanced level) week7-8 Kinect rally ball (intermediate and advanced level) total 8 weeks. 3 days per week session will be given for 30 minutes including 5 minutes warm up and cool down and 5 minutes of break in between to avoid fatigue.

Procedure: INTERVENTION GROUP; TRAINING WITH EXERGAMING

Control Group

ACTIVE COMPARATOR

The participant will receive task oriented training consisting of different tasks in sitting and standing position. week1-2 sitting position: throwing and catching balls standing position: picking up glass from less heighted table . week 3-4 sitting position: transferring the plastic rings from one corner of table to another. standing position: catching balls from multiple directions. wee5-6 sitting position: picking objects from floor standing position: opening drawer from less heighted tables week 7-8 standing position: picking up and transferring bottles, jars at different locations on table standing position: removing stickers from wall time of session: 15-20 repetitions, 2 sets. 30 minutes of session with 5 minutes rest in between. the intervention will be given for 30 minutes , 3 days a week for total 8 weeks of time period.

Procedure: Task oriented training

Interventions

RANDOMIZED CONTROL TRIAL EXERGAMING KINECT 20,000 LEAKS , KINECT BUBBLE POP, KINECT RALLY BALL GROUP 2: TASK ORIENTED TRAINING TRANSFERRING OBJECTS FROM ONE SIDE TO OTHER SIDE OF TABLE CATCHING AND THROWING BALLSIN DIFFERENT DIRECTIONS PICKING UP OBJECTS FROM LESS HIGHTED TABLES.

Interventional Group

The participant will receive task oriented training consisting of different tasks in sitting and standing position. week1-2 sitting position: throwing and catching balls standing position: picking up glass from less heighted table . week 3-4 sitting position: transferring the plastic rings from one corner of table to another. standing position: catching balls from multiple directions. wee5-6 sitting position: picking objects from floor standing position: opening drawer from less heighted tables week 7-8 standing position: picking up and transferring bottles, jars at different locations on table standing position: removing stickers from wall time of session: 15-20 reps, 2 sets. 30 minutes of session with 5 minutes rest in between. the intervention will be given for 30 minutes , 3 days a week for total 8 weeks of time period.

Control Group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with sub-acute post-stroke.
  • Aged 40 years-85 years.
  • Mini-mental status examination \>24
  • Motor assessment scale (1-5 scoring)

You may not qualify if:

  • Post-stroke patients with major cognitive deficits.
  • Acute infections.
  • Patients with any fracture/ MSK disorders.
  • Neurological deficits other than stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 46000, Pakistan

Location

MeSH Terms

Interventions

Exergaming

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

November 14, 2024

First Posted

February 25, 2025

Study Start

July 10, 2024

Primary Completion

December 1, 2024

Study Completion

December 20, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations