NCT07686952

Brief Summary

This research study aims to evaluate the effectiveness of Kinect-based upper extremity exergaming in improving trunk control, postural stability, upper limb function, and quality of life among individuals recovering from stroke. A randomized controlled trial will be conducted, enrolling 40 participants between the ages of 40 and 60 years, within three months post-stroke. Participants will be randomly allocated into two groups: one group will receive Kinect-based virtual reality upper limb training, while the other will undergo conventional task-oriented upper extremity rehabilitation. Both groups will additionally receive standard physiotherapy as required. The intervention will span eight weeks, comprising three sessions per week, each lasting 30 to 45 minutes. Outcome measures will be assessed at baseline, at the fourth week, and at the conclusion of the eighth week using validated tools including the Trunk Impairment Scale, Postural Assessment Scale for Stroke Patients (PASS), Modified Functional Reach Test, Fugl-Meyer Assessment for Upper Extremity, Wolf Motor Function Test, and Stroke-Specific Quality of Life Scale. By examining the potential cross-regional benefits of upper limb virtual reality-based training on trunk control and postural stability, this study seeks to contribute to the development of evidence-based, technologically integrated rehabilitation protocols for stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2025

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

March 15, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

Upper ExtremityKinectExergamingTrunk ControlPostural StabilityStroke Patients

Outcome Measures

Primary Outcomes (6)

  • Trunk control

    Trunk Impairment Scale was used to measure trunk control. * 0-7 points: Severe impairment of trunk control. * 8-16 points: Moderate impairment of trunk control. * 17-23 points: Mild or no impairment of trunk control.

    8 weeks

  • Trunk Control

    Modified Functional Reach test * 15.2 to 17.8 cm limited functional balance and an elevated risk of falling * 25.4 cm Healthy Independent, no fall risk

    8 weeks

  • Postural Stability

    Postural Assessment Scale for Stroke Patients (PASS) * 0 = Unable to perform the task. * 1 = Requires substantial assistance. * 2 = Requires minimal assistance. * 3 = Can perform the task independently. * Total Score Range: 0 to 36 points (higher scores indicate better postural control).

    8 weeks

  • Upper Extremity function

    Fugyl Meyer Scale (FMA -UE) * 0-19 points: Severe impairment * 20-47 points: Moderate impairment * 48-66 points: Mild impairment or near-normal function

    8 weeks

  • Upper Extremity function

    Wolf Motor Function test * 0-25: Severe impairment * 26-50: Moderate impairment * 51-75: Mild to no impairment

    8 weeks

  • Quality of life of patients

    Stroke-Specific Quality of Life Scale (SS-QoL) Scores range from 49 (worst) to 245 (best).

    8 weeks

Study Arms (2)

Kinect-Based Upper Extremity Exergaming

EXPERIMENTAL

Each session includes a 5-minute warm-up, 35 minutes of active gameplay (combination of selected exergames), and a 5-minute cool-down period. Sessions occur three times per week for eight weeks, totaling 24 supervised sessions. The complexity and intensity of the games are progressively adjusted based on the participant's functional ability. Cuff weights (½ kg to 1 kg) are introduced from week 5 onwards to increase resistance and promote strength gains. Participants progress through predefined game levels, beginning with basic motor tasks and advancing to more complex, multijoint coordination activities.

Procedure: Group A

Task oriented exercises

ACTIVE COMPARATOR

The training protocol is delivered three times per week for eight weeks, matching the frequency and duration of Arm A. Each session lasts 45 minutes, including a warm-up and rest periods. Each task is repeated for 10-15 repetitions per set, with two sets per task, and modified based on the participant's ability and fatigue level. From week 5 onwards, light cuff weights (½ to 1 kg) are incorporated to challenge muscle endurance and strength. All exercises are demonstrated by the therapist before practice, and patients are encouraged to perform them with minimal compensation and maximal control.

Procedure: Group B

Interventions

Group APROCEDURE

The exergames include: * Boxing: Involves bilateral upper limb movements such as punching, blocking, and arm elevation, requiring shoulder flexion/extension, elbow flexion/extension, wrist motion, and trunk rotation. * Bowling: Involves reaching to one side, grasping, and swinging the arm forward with balance control and anticipatory trunk adjustments. * Table Tennis: Requires quick arm movements, shoulder internal/external rotation, elbow flexion, forearm supination, and wrist coordination, with trunk stabilization during rapid directional shifts. * Bubbles in Space: Involves flapping arms, reaching upward and laterally, simulating a zero-gravity environment. Participants must maintain arm elevation and trunk symmetry to "pop" virtual bubbles floating across the screen. * Volleyball: Involves tossing and hitting motions with one or both arms, requiring coordinated trunk rotation and controlled postural reactions.

Kinect-Based Upper Extremity Exergaming
Group BPROCEDURE

* Reaching for an item on a high shelf: Promotes shoulder flexion and trunk extension. * Throwing a ball toward the therapist: Involves shoulder external rotation, elbow extension, and trunk rotation. * Picking up a cup from a table and bringing it to the mouth: Simulates eating or drinking tasks and promotes hand-to-mouth coordination. * Reaching across the body to grab an object: Requires shoulder adduction, trunk rotation, and balance control. * Lifting an object from the floor and placing it on a table: Integrates trunk flexion with controlled upper limb lifting and placement.

Task oriented exercises

Eligibility Criteria

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

You may qualify if:

  • Sub acute and Chronic Stroke (\>3 months)
  • Both genders
  • Age 40 years and above.
  • Patient able to stand with eyes close for 10 seconds
  • Patient able to understand commands
  • TUG more than \>20
  • UL Fugyl Meyer Score (UL-FMS) \< 30/66

You may not qualify if:

  • Patient with history of active Fits and recurrent stroke attacks.
  • Patients with neurological disorders other than stroke
  • Patient with uncontrolled systemic disorders ( DVT, CABG, IHD, CHD, CPD, pacemaker use)
  • Severe Musculoskeletal and orthopedic disorders.
  • Patients diagnosed with Psychiatric disorder
  • Pain in the hemiplegic shoulder NPRS \>4
  • Patients with diagnosed vestibular impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 46000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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

June 30, 2026

First Posted

July 7, 2026

Study Start

March 15, 2025

Primary Completion

May 10, 2026

Study Completion

May 15, 2026

Last Updated

July 7, 2026

Record last verified: 2026-06

Locations