Modulation of Upper Limb Spasticity Post-Stroke

Umm Al-Qura University

Status: Completed

Conditions: Spasticity as Sequela of Stroke; Upper Extremity Dysfunction; Spastic Hemiplegia

Treatments: Other: Traditional physical therapy program; Device: Virtual reality-based training equipment.

Study type: Interventional

Funder types: Other

Identifiers

NCT05069480

ID MED99-10 -14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Participants who participated in the control group received a traditional physical therapy program for two hours. It included two parts, each of them was one hour and few minutes rest in between. The first part included: reflex inhibiting patterns, strengthening activities, stretching exercises, and postural reactions exercises. The second part included: arm-reaching tasks, arm-hand tasks, hand manipulative tasks for the more affected upper limb through performing functional tasks of daily living activities. The traditional intervention was carried out three sessions per week for twelve successive weeks.

Treatment:

Other: Traditional physical therapy program

Experimental Group

Experimental group

Description:

Participants of the experimental group have received two hours treatment program that included three parts, the first and the second parts were similar to that applied for participants in the control group for one hour followed by few minutes rest, then the third part was applied for one hour. The third part included a virtual reality intervention program by using virtual reality equipment to simulate a range of upper limb tasks related to arm-hand activities and hand manipulative tasks through using different games and soft-wares. The treatment program for the experimental group was carried out three sessions per week for twelve successive weeks.

Treatment:

Other: Traditional physical therapy program

Device: Virtual reality-based training equipment.