Mirror Therapy and Augmented Reality in Stroke Rehabilitation
ConditionStroke Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorNational Taiwan University Hospital
About this trial
This research is in line with the National Health Research Institutes (NHRI) Innovative Research Grant priority to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that leads to long-term disability and causes a heavy health care and financial burden. To meet multidimensional needs of patients with stroke, hybrid interventions that combine different approaches are needed due to the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation, particularly in the priming and synergic effects of robotic-assisted training and/or mirror therapy (MT). To extend from our previous research, the investigators will combine MT with augmented reality (AR), an emerging adjunct therapy in stroke rehabilitation. An AR-based intervention provides an intensive, repetitive, and context-rich training program, leading to an interesting environment with real-time feedback to increase motivation and participation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
a first-ever unilateral stroke ≥3 months and ≤3 years
age between 30 and 80 years (Kwakkel et al., 1999)
baseline Fugl-Meyer Assessment Upper Extremity (FMA-UE) score >10 (Fugl-Meyer et al., 1975)
no severe spasticity in any joints of the affected arm (modified Ashworth scale <3) (Charalambous, 2014)
Disqualifiers
acute inflammation
serious medical problems or poor physical conditions that might be detrimental to study participation.
Trial design
Design model
Parallel
Treatments tested in this trial
mirror therapy (MT)
Other interventionEach participant will practice two different MT protocols: UMT and BMT. During UMT, the affected hand is static, whereas during BMT, the affected hand moves in an attempt to duplicate the unaffected hand as best as possible. The MT activities include gross motor movements (i.e., shoulder flexion, elbow flexion/extension, forearm pronation/supination, and wrist flexion/extension and circumduction), fine motor movements (i.e., opposition, grasp, and release), and object manipulation (i.e., reaching out to grasp a cup, flipping coins).
augmented reality (AR)
Other interventionThe training program with different levels of difficulty provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg, etc.), activities of daily living training (i.e., reaching to grasp functionally relevant objects), and cognitive enhancement (i.e., memory training). By using the AR system, participants can observe the real performance of motions and interaction between the body and the virtual environment.
Control intervention
Other interventionParticipants will perform 90 minutes of therapist-mediated conventional therapy. The treatment protocols will be formulated by using occupational therapy techniques, such as neurodevelopmental techniques and functional task training. Specifically, the affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques will be used to alleviate functional deficits. In addition, the therapist will work with the participant to select functionally relevant tasks, such as picking up items from a box, lifting soft drink bottles, hanging clothes, and so on.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: MT+AR groupExperimental treatment 2 interventions
Group B: AR groupActive comparator 1 intervention
Group C: CT groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer Assessment (FMA)
The upper-extremity subscale of the FMA will be used for the assessment of motor impairment. Movements and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed are scored. Each score is on an ordinal scale of 3 points (0 = cannot perform, 1 = performs partially, 2 = performs fully). The highest score is 66, which indicates optimum recovery. The subscale score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be calculated to study the effects of treatment on separate elements of the upper extremities. The FMA has good reliability, validity, and responsiveness in stroke.
Time frame
Baseline, 6 weeks, and 18 weeks2
Berg Balance Scale (BBS)
The BBS is identified as one of the most widely used evaluation tools of balance across the continuum from acute clinic-based to community-based care. There are 14 items assessing the patient's ability to maintain balance, either statically or with a variety of functional movements, over a given time period. Each score is on a 5-point ordinal scale (0 = inability to complete the task, 4 = independent item completion). The maximum score is 56, representing good balance. The BBS is a reliable and valid tool in assessing balance and functional mobility for stroke.
Time frame
Baseline, 6 weeks, and 18 weeksSecondary outcomes
1
Revised Nottingham Sensory Assessment (rNSA)
The rNSA will be used to assess changes of sensation. Various sensory assessments will be used to evaluate the tactile sensation, proprioception, and stereognosis of the various body segments. The rNSA rating is based on an ordinal scale of 3 points (0-2), with a lower score indicating more sensory impairment. Its psychometric properties have been determined for stroke.
Time frame
Baseline, 6 weeks, and 18 weeks2
Chedoke Arm and Hand Activity Inventory (CAHAI)
The CAHAI evaluates the functional ability of the affected arm and hand to perform tasks after stroke. The 13 items contained in the CAHAI represent bimanual meaningful everyday activities and are made up a variety of the upper-extremity characteristics, including strength, dexterity, coordination, and grasp. The 7-point activity scale is used in the CAHAI, where 1 indicates "performing less than 25% of the effort to complete the task" and 7 indicates "the participants' affected upper extremity is able to complete the task competently independently." The reliability and validity of the CAHAI have been ascertained in stroke.
Time frame
Baseline, 6 weeks, and 18 weeks3
Motor Activity Log (MAL)
The MAL is a self-reported semistructured interview that rates the frequency of use (MAL-amount of use \[AOU\]) and quality (MAL-quality of movement \[QOM\]) of the affected upper extremity. It consists of 30 functional tasks in real life, such as turning on a light with a light switch, opening a refrigerator, or washing hands (Silva et al., 2018; Van der Lee et al., 2004). The scale ranges from 0 to 5 (0 = did not use the affected arm, 1 = occasionally used the affected arm but only very rarely/the affected arm was moved during that activity but was not helpful, 5 = used the affected arm as often as before the stroke/the ability to use the affected arm for that activity was as good as before the stroke). Its reliability and validity have been confirmed in stroke (Silva et al., 2018).
Time frame
Baseline, 6 weeks, and 18 weeks4
Stroke Impact Scale Version 3.0 (SIS 3.0)
The SIS 3.0 measures stroke-specific health-related quality of life (Duncan et al., 2003). It includes 59 items assessing eight domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory, and thinking and participation), with a single item evaluating the overall perceived recovery of the stroke. Items are graded on a 5-point Likert scale, with lower scores indicating higher difficulty in completing the tasks over the past week. The SIS 3.0 has satisfactory reliability, validity, and responsiveness in patients with stroke (Duncan et al., 2003).
Time frame
Baseline, 6 weeks, and 18 weeksSponsors and contacts
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Source ClinicalTrials.gov