Motor Rehabilitation of Upper & Lower Extremity of Stroke Clients

recoveriX for Stroke
Study Results

Upper Extremity Training

The efficacy of recoveriX was shown in a group study of 52 clients. The 51 clients who finished the treatment showed highly significant improvements in upper extremity motor function and spasticity. Furthermore, the improvements facilitated by recoveriX were found to be long lasting in nature. Time since stroke, age and baseline impairment did not affect the motor function improvements experienced by clients. The functional improvements experienced can be explained by neuroplastic changes in the central nervous system.

The primary outcome measure of the recoveriX PRO study was the upper extremity Fugl-Meyer Assessment (FMA-UE). The FMA-UE is recommended for evaluating upper extremity motor function after stroke [1,2] and has excellent inter-rater reliability [3,4].

The table below shows the client characteristics of the 51 clients who finished the treatment, with 23 of them being female.

Median Range
Age (years) 62.0 13-86 years
Time Since Stroke (months) 36.5 3 months – 31 years
FMA-UE in PRE (points) 19.0 3-59 points

 

The baseline impairment of clients was on median 19.0 points with 35, 9 and 7 clients being severely, moderately and mildly impaired, respectively [5].
Clients improved on average by 4.8 points in FMA-UE. Performing a statistical test (two-tailed paired t-test) resulted in a highly significant difference in mean FMA-UE scores before and after recoveriX treatment.

If one splits clients by their degree of impairment according to Woytowicz et al. (2017) [5] we observed that severely impaired clients improved by 3.7 points, moderately impaired clients improved by 8.0 points and mildly impaired clients improved by 5.3 points. Below a figure is shown for the different client groups.

FMA-UE Improvements in the scientific study recoverix

FMA-UE improvement for the different client groups shown in mean and 95% Confidence Interval. ALL: all 51 clients who participated in the study. SEVERE: severely impaired clients (n=35). MODERATE: moderately impaired clients (n=9). Mild…mildly impaired clients (n=7)

 

Page et al. (2012) [6] defined the clinically important difference for moderately to minimally impaired clients in chronic stroke to be 4.25 to 7.25 points in FMA-UE. Clinically important difference refers to the improvement that is considered meaningful for the client. For moderately impaired clients recoveriX achieved 8.0 points, which is greater than the clinically important difference. For minimally impaired clients recoveriX achieved 5.3 points, which is in the range of the clinically important difference.
In comparison, studies using just FES (i.e., without a BCI) reached a mean improvement of 3.9 points in FMA-UE.

Clients who are able to control the recoveriX system very well (median classification accuracy >80%) improved by 6.5 points, whereas people who had a median classification accuracy <80% improved by 2.3 points. This shows that active engagement and motivation are of importance, when training with the recoveriX system. Importantly, the ability to control the recoveriX system is independent from baseline impairment!

Additionally, the following clinical scales show significant improvements [7,8]:

  • Barthel Index
  • Modified Ashworth Scale for Wrist and Fingers
  • Box and Block Test of the affected and healthy hand
  • 9-Hole Peg test for the healthy hand
  • Fahn Tremor Rating Scale of the affected and healthy hand
  • Montreal Cognitive Assessment
  • Stroop Color-Word Test

Note that in the study we did not observe a significant improvement in 9-Hole Peg test for the affected hand. This is because only 9 out of 51 clients could even perform this test, because it requires substantial fine motor skills

Lower Extremity Training

The efficacy of our recoveriX lower extremity training was investigated in 25 stroke clients. As three clients withdrew their participation 22 clients remained with 9 of them being female. 21 clients were in their chronic phase and one was in their subacute phase. The primary outcome measure was gait speed, assessed using the 10-Meter Walk Test (10MWT). All clients performed 25 sessions of one hour of recoveriX training distributed across 3 times per week.

Clients’ 10MWT improved significantly by 1.0 second. In other words, clients were able to complete the 10MWT quicker after the recoveriX training. In terms of gait speed clients also showed a significant improvement by 0.16 m/s with the mean improvement in gait speed being 0.19 m/s.

These results show that clients’ gait speed, assessed by the 10MWT, improved significantly. In fact, this improvement exceeds the substantial meaningful change defined by Perera et al. (2006) [9]. Clients show a significant improvement in gait speed after 21 sessions (analyzed using a repeated measure analysis). Therefore, the protocol based on 25 sessions distributed across 3 times per week, was found to be a good dosage.

Additionally, the following clinical scales show significant improvements:

  • Barthel Index
  • Modified Ashworth Scale for Ankle
  • Range of Motion in Ankle
  • Manual Muscle Test for Knee and Ankle
  • Timed Up and Go test
  • Montreal Cognitive Assessment

Comparison of recoveriX with other treatments

We chose to compare our recoveriX lower extremity training with one of the most effective treatments in the literature for gait rehabilitation in stroke clients: Electromechanical Gait Training with End Effector devices (EGAIT-EE). EGAIT-EE was identified to be the most effective by performing a meta-analysis. The meta-analysis originally included 95 randomized controlled trials with a total of 4458 clients. The primary measure used to evaluate the walking ability was the gait speed. The EGAIT-EE group improved significantly in gait speed compared with the control group by 0.15 m/s on average (P < 0.001).

Clients in their chronic phase showed a change in gait speed of 0.11 m/s in the EGAIT-EE group [10]. In comparison for recoveriX we observed an improvement of 0.19 m/s. Importantly, recoveriX does not need the use of a body weight support system as clients are seated during the recoveriX training. Therefore, the risk of falls is completely eliminated, while clients can still train their gait patterns and increase their motor functions, gait speed, coordination and balance.

FMA-UE Improvements in the scientific study recoverix

10MWT Improvement reflecting the increase in GAIT speed in m/s for EGAIT-EE and recoveriX treatment.

recoveriX is compared to many control groups

Many people ask us why we do not have control groups in these studies. The simple answer is that a medical product has to be compared with many other technologies and scientific results on the market and this must be updated every year. For medical products a clinical evaluation has to be performed in order to get the medical approval from a notified body. This clinical evaluation is reviewed by the clinical evaluation center of the notified body, which is the unit responsible for bringing medical products to the market that are safe and effective.

The recoveriX system was compared with many independent studies using different techniques. Important to note here is that in this way recoveriX was compared to many different control groups and scientific study results and that a medical product gets the certification only if it is effective and safe. Finally, this clinical evaluation showed that recoveriX is effective and safe.

Clinical Scales and Tests

The Upper Extremity Fugl-Meyer Assessment (FMA-UE) is an assessment for evaluating and quantifying motor function of the upper extremity in stroke clients. The scale ranges from 0 to 66 points, with 66 points being the best motor function a client can have.

  • The Barthel Index is a subjective questionnaire in which clients rate their performance in Activities of Daily Living.
  • The Modified Ashworth Scale assesses spasticity of different joints of the affected side.
  • The Box and Blocks Test assess hand dexterity.
  • The 9-Hole Peg Test assesses finger dexterity.
  • The Fahn Tremor Rating Scale assesses the tremor degree of the upper extremity.
  • The Montreal Cognitive Assessment assesses cognitive function and impairment.
  • The Stroop Color-Word Test assesses the ability to process two cognitively interfering stimuli (see Stroop Effect).
  • The 10-Meter Walk Test assesses the gait speed.
  • The Manual Muscle Test assesses muscle strength and function.
  • The Timed Up and Go Test assess the mobility and requires balance and coordination.

The benefit of performing both the upper and lower extremity treatment

Is it beneficial to perform another recoveriX treatment block (i.e., 25 training sessions for stroke) after finishing the first recoveriX treatment block? The short answer is Yes, because further motor function improvements are still possible especially if you have responded well to the first recoveriX treatment block. As always, we have the data to back up this conclusion, so let’s look at it.

Eighteen stroke clients participated in at least one recoveriX treatment block, before they started their recoveriX lower extremity treatment block (i.e., foot training). Across their previous treatment block, they improved significantly by 4.8 points in upper extremity motor function on average. Then these 18 stroke clients participated in the recoveriX lower extremity treatment block and we observed significant improvements in the following clinical scales:

  • Barthel Index
  • Upper and Lower Fugl-Meyer Assessment
  • Modified Ashworth Scale of the ankle joint
  • Range of motion of the ankle and knee joint
  • Manual Muscle Test of the knee and ankle
  • Timed Up and Go Test
  • 10-Meter Walk Test

Taking a closer look at the walking velocity, which is assessed using the 10-Meter Walk Test, we could observe an improvement by 0.14 m/s on average. In other words, the clients could walk 0.5 km/h faster after their recoveriX lower extremity treatment block.

before and after results of recoveriX training

Before/After Results of recoveriX Training

This client performed the 10 meter walk test is a clinical assessment used to measure an individual’s walking speed over a short distance, employed to evaluate mobility and functional capacity.

This client performed the 9-hole peg test here. This test is a standardized assessment used to measure manual dexterity by timing how quickly an individual can manipulate and place nine pegs into a pegboard and then remove them one by one.

This client performed the 9-hole peg test here. This test is a standardized assessment used to measure manual dexterity by timing how quickly an individual can manipulate and place nine pegs into a pegboard and then remove them one by one.

This client performed the 9-hole peg test here. This test is a standardized assessment used to measure manual dexterity by timing how quickly an individual can manipulate and place nine pegs into a pegboard and then remove them one by one.

This client performed the 9-hole peg test here. This test is a standardized assessment used to measure manual dexterity by timing how quickly an individual can manipulate and place nine pegs into a pegboard and then remove them one by one.

This client performed the 9-hole peg test here. This test is a standardized assessment used to measure manual dexterity by timing how quickly an individual can manipulate and place nine pegs into a pegboard and then remove them one by one.

This client performed the 9-hole peg test here. This test is a standardized assessment used to measure manual dexterity by timing how quickly an individual can manipulate and place nine pegs into a pegboard and then remove them one by one.

This client performed the 9-hole peg test here. This test is a standardized assessment used to measure manual dexterity by timing how quickly an individual can manipulate and place nine pegs into a pegboard and then remove them one by one.

Here this client performed the Box and Block Test which evaluates manual dexterity and gross motor skills by assessing how many wooden blocks a participant can transfer from one compartment to another within a set time frame. It’s commonly used in rehabilitation to track progress and tailor treatment plans for individuals with upper extremity impairments.

Here this client performed the Box and Block Test which evaluates manual dexterity and gross motor skills by assessing how many wooden blocks a participant can transfer from one compartment to another within a set time frame. It’s commonly used in rehabilitation to track progress and tailor treatment plans for individuals with upper extremity impairments.

Here this client performed the Box and Block Test which evaluates manual dexterity and gross motor skills by assessing how many wooden blocks a participant can transfer from one compartment to another within a set time frame. It’s commonly used in rehabilitation to track progress and tailor treatment plans for individuals with upper extremity impairments.

Here this client performed the Box and Block Test which evaluates manual dexterity and gross motor skills by assessing how many wooden blocks a participant can transfer from one compartment to another within a set time frame. It’s commonly used in rehabilitation to track progress and tailor treatment plans for individuals with upper extremity impairments.

Here this client performed the Box and Block Test which evaluates manual dexterity and gross motor skills by assessing how many wooden blocks a participant can transfer from one compartment to another within a set time frame. It’s commonly used in rehabilitation to track progress and tailor treatment plans for individuals with upper extremity impairments.

Here this client performed the Box and Block Test which evaluates manual dexterity and gross motor skills by assessing how many wooden blocks a participant can transfer from one compartment to another within a set time frame. It’s commonly used in rehabilitation to track progress and tailor treatment plans for individuals with upper extremity impairments.

Here this client performed the Box and Block Test which evaluates manual dexterity and gross motor skills by assessing how many wooden blocks a participant can transfer from one compartment to another within a set time frame. It’s commonly used in rehabilitation to track progress and tailor treatment plans for individuals with upper extremity impairments.

References

Sebastián-Romagosa, M., Cho, W., Ortner, R., Sieghartsleitner, S., Von Oertzen, T.J., Kamada, K., Laureys, S., Allison, B.Z. and Guger, C., Brain-Computer Interface Treatment for Gait Rehabilitation in Stroke Patients. Frontiers in Neuroscience17, p.1256077. doi:10.3389/fnins.2023.1256077

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