Clinical trial NCT05069480: Modulation of Upper Limb Spasticity Post-Stroke
Official title: Interactive Game-Based Rehabilitation for Controlling Upper Limb Spasticity Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity as Sequela of Stroke
Spastic Hemiplegia
Upper Extremity Dysfunction
Keywords: Spasticity , Stroke ,Upper Extremity,Rehabilitation.
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is one of the commonest causes of severe disability in adults. Stroke often results in spasticity and motor impairments in the upper limb. Permanent upper extremity impairments can lead to limitations in activities of daily living, social participation, and quality of life. Spasticity may obscure motor learning ability after stroke. Spasticity control is one of the main aims of most therapists in the rehabilitation process for patients with chronic stroke. Traditional approaches for managing spasticity may not be enough for gaining satisfactory results. Virtual reality-based therapy is one of the most innovative and developments in rehabilitation technology. It could be effective in accelerating motor recovery and modulating spasticity for the involved upper limbs. The purpose of this study was to examine the impact of virtual reality-based therapy on upper limb spasticity and motor functions in patients post-stroke.

Detailed description: Stroke is an acute, medical event, which mainly results in neurological damage leading to disability and mortality. Stroke is a common, serious, and disabling problem. The most widely recognized impairment caused by stroke is motor impairment of one side of the body called hemiplegia, which restricts function in muscle movement or mobility. Following a stroke, many upper limb impairments may influence the patient's ability to perform functional activities. These include spasticity, muscle weakness, restricted and in-coordinated movement. The impact of upper limb dysfunctions on participation in home, work, community life, and daily living activities is great. Upper limb recovery after stroke is unacceptably poor; with only 50% of stroke survivors likely to regain some functional use. In many neurological disabilities associated with spasticity such as hemiplegia post-stroke, the rehabilitation process is of long duration and clinicians face the challenge of identifying a variety of meaningful and motivating intervention tasks that could be effective in controlling spasticity and preventing its negative hazards. Current rehabilitation techniques have focused on teaching and reinforcing different strategies that encourage the use of the non-involved upper extremity to decrease functional limitations. Treatment options for controlling spasticity and enhancing upper limb functions include physical therapy, occupational therapy, neurodevelopmental therapy, peripheral splinting and casting, constrained induced movement therapy, pharmacotherapy (e.g., botulinum toxin type A), and surgery. Till now, there is a lack of strong evidence of successful treatment with any of these approaches. Virtual reality is a relatively recent approach to stroke rehabilitation. It has been shown to be an interactive and enjoyable medium that, with sufficient use, may improve upper limb motor function in adults with stroke. Enhanced feedback provided by a virtual reality system has been shown to promote motor learning in normal subjects. The main advantage of virtual game-based rehabilitation over conventional approaches is the inclusion of an interactive and motivating exercise environment. Until now, there have been limited researches involving the inclusion of virtual reality-based therapy systems in neuro-rehabilitation and spasticity management of the involved upper limb for hemiplegic patients post-stroke. Therefore, the purpose of this study was to evaluate the efficacy of virtual reality technology on modulating spasticity and improving the function of the involved upper extremity in patients having a chronic stroke.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria were as follow:

* Participants were diagnosed as chronic stroke patients.
* Participants were selected to be in the spastic phase, 6-24 months following a first stroke.
* The degree of spasticity in the affected upper limbs, was ranged between grades (1, 1+\&2) according to Modified Ashworth Scale.
* Participants were all between 50 and 60 years old, of both sexes.
* Participants were cognitively able to understand and follow instructions.
* Participants had the ability to extend their wrist joints at least 20° and ﬁngers 10° from full ﬂexion. This range allowed participants to engage easily in performing a designed functional program.

Exclusion Criteria:

The exclusion criteria were as follow:

* Participants who were with any orthopaedic condition or fixed deformity that interfere with the upper limb functions.
* Participants who were with spasticity more than score 2 according to the Modified Ashworth Scale.
* Participants who had cognitive or perceptual problems.
* Participants with surgical interference for the upper limb and spine within the previous 2 years.
* Participants with seizures, visual impairments, or auditory problems.
* Participants who had shoulder pain on a visual analogue scale of \> 6/10.
* Participants who had Botulinum Toxin in the upper extremity musculature six months before baseline assessment.

Primary outcomes:
measure: Change in the score of The Wolf Motor Function Test (test that assess the change in upper extremity motor ability)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between The Wolf Motor Function Test Score at both baseline and completion of 12 weeks of intervention)
measure: Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 12 weeks of intervention)
measure: Change in the Modified Ashworth Scale (scale that assess the change in muscle tone)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between the degree of muscle tone at both baseline and completion of 12 weeks of intervention)
Secondary outcomes:
measure: Change in the upper limb' joints range of motion (in degree)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between the degree of upper limb' joints range of motion at both baseline and completion of 12 weeks of intervention)
measure: Change in the Hand Grip Strength of the involved upper extremity (Kg) (which indicate the change of the strength of the involved hand muscles in patients with stroke).
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between hand grip strength at both baseline and completion of 12 weeks of intervention)
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Ehab Abd El Kafy
Study officials:
affiliation: Professor of Physical Therapy -Umm Al Qura University.
name: Ehab M Abd El Kafy, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abd El-Kafy EM, Alshehri MA, El-Fiky AA, Guermazi MA, Mahmoud HM. The Effect of Robot-Mediated Virtual Reality Gaming on Upper Limb Spasticity Poststroke: A Randomized-Controlled Trial. Games Health J. 2022 Apr;11(2):93-103. doi: 10.1089/g4h.2021.0197. Epub 2022 Jan 31.