Modulation of Upper Limb Spasticity Post-Stroke

NCT05069480 | Completed

• 1 other identifier: ID MED99-10 -14
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Spasticity , Stroke ,Upper Extremity,Rehabilitation.

Outcome Measures

Primary Outcomes (3)

• Change in the score of The Wolf Motor Function Test (test that assess the change in upper extremity motor ability)

  The Wolf Motor Function Test (WMFT) is designed to assess upper extremity motor abilities in patients with stroke through timed and functional tasks. The WMFT consists of 15 timed items (6 items involve timed functional tasks, and 9 items consist of analyzing movement quality when completing various tasks), in addition to 2 items (7\&14) are measures of strength. The examiner should test the less affected upper extremity followed by the most affected side. The 15 timed items are rated on a 6-point functional ability scale (0-5), score (0) means the patient is unable to use UE being tested while score (5) means the patient is able to use it and movement appears to be normal. The total score on the WMFT ranges from 0 to 75. Lower scores are indicative of lower functioning levels. Thus, the higher the score a patient get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity (UE) motor abilities.

  [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)

• Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions)

  The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals with hemiplegia. It assesses a patient's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement. The ARAT is scored on a four-level ordinal scale (0-3): 0 = cannot perform any part of the test, 1 = performs partially, 2 = take long time to complete the test, and 3 = performs the test normally. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, the higher the score a patient get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions.

  [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)

• Change in the Modified Ashworth Scale (scale that assess the change in muscle tone)

  Modified Ashworth Scale was used to evaluate the degree of spasticity in the involved upper limb in the elbow and wrist joints. MAS is a valid and a reliable scale to evaluate the degree of muscle tone for all participants pre and post treatment. It is scored on a 6 -graded ordinal scale.

  [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 (2)

• Change in the upper limb' joints range of motion (in degree)

  [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)

• 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).

  [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)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Other: Traditional physical therapy program

Experimental Group

EXPERIMENTAL

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.

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

Interventions

Virtual reality-based training equipment. DEVICE

It is a functional upper extremity rehabilitation device to provide specific therapy with augmented feedback. The equipment facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury, or other neurological diseases and injuries. It combines adjustable arm support, with augmented feedback and a large 3D workspace that allows functional therapy exercises in a virtual reality environment.

Experimental Group

Traditional physical therapy program OTHER

The traditional physical therapy program aimed for inhibition of spasticity, facilitation of muscle action, and improving the motor functions of the involved upper limbs.

Control Group; Experimental Group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Ehab Abd El Kafy

Mecca, 21955, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 35100025 DERIVED

MeSH Terms

Conditions

Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Ehab M Abd El Kafy, Ph.D

  Professor of Physical Therapy -Umm Al Qura University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 6, 2021
• Study Start: October 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: tart Date: Beginning one year following main results publication End Date: Ending two years following main results publication
• Access Criteria: Data can be obtained by Principal Investigator Email Address: emkafy@uqu.edu.sa

Locations

SA (1)