Chronic Stroke
Conditions
Keywords
Stroke rehabilitation, Balance training, Distal control, Postural stability, Neuroplasticity, Virtual assessment tools
Brief summary
Study will include two different intervention groups. Both groups will receive a standardized 50-minute multimodal rehabilitation program consisting of 30 minutes of Bobath-based exercises, 10 minutes of neuromuscular electrical stimulation (NMES) applied to the hemiparetic limb, and 10 minutes of bicycle ergometer training. In addition, both groups will receive 15 minutes of technology-assisted balance training, 5 days per week for 4 weeks. Group 1 will receive distal (ankle-strategy) balance training (DBT) using the Technobody Prokin system, including interactive "Game Pong" tasks with controlled anteroposterior and mediolateral platform displacement. Group 2 will receive proximal (hip-strategy) balance training (PBT) using the TheraTrainer Balo device. Study Aim: To investigate and compare the effects of technology-assisted distal (ankle-strategy) versus proximal (hip-strategy) balance training, each added to a standardized multimodal rehabilitation program, on balance, posture and functional outcomes in individuals with chronic stroke.
Detailed description
This prospective, participant- and assessor-blinded, two-group parallel randomized controlled trial included 46 participants aged 65-85 years with chronic stroke. Participants were randomly assigned in a 1:1 ratio to distal balance training (DBT) or proximal balance training (PBT), with 23 participants allocated to each group. All participants received a standardized 50-minute multimodal rehabilitation program consisting of 30 minutes of Bobath-based therapeutic exercises, 10 minutes of neuromuscular electrical stimulation (NMES), and 10 minutes of bicycle ergometer training. In addition, participants received 15 minutes of technology-assisted balance training, 5 days per week for 4 weeks. Participants in the DBT group received ankle-strategy-based balance training using the Technobody Prokin system. Training included interactive "Game Pong" tasks requiring controlled anteroposterior and mediolateral platform displacement. Participants in the PBT group received hip-strategy-based balance training using the TheraTrainer Balo device, which provided visual feedback during multidirectional trunk and pelvic control tasks. Functional outcomes were assessed using the Timed Up and Go Test (TUG), 5-Repetition Sit-to-Stand Test (SST), and Functional Independence Measure (FIM). Balance was assessed using the Berg Balance Scale (BBS), Functional Reach Test (FRT), Trunk Impairment Scale (TIS), and Single-Leg Stance Test (SLST). Postural sway was assessed using the Technobody force platform, and postural alignment was assessed using the PostureScreen Mobile application. Cognitive status was assessed using the Standardized Mini-Mental Test (SMMT), which was administered once before treatment. All other outcome assessments were performed at baseline and after 4 weeks of rehabilitation.
Interventions
DEVICETechnoBody intervention
Participants will receive distal (ankle-strategy) balance training using the Technobody Prokin system for 15 minutes per session, 5 days per week for 4 weeks. In addition, participants will receive the standardized multimodal rehabilitation program consisting of 30 minutes of Bobath-based exercises, 10 minutes of neuromuscular electrical stimulation (NMES) applied to the hemiparetic limb, and 10 minutes of bicycle ergometer training.
DEVICEThera-Trainer intervention
Participants will receive proximal (hip-strategy) balance training using the TheraTrainer Balo device for 15 minutes per session, 5 days per week for 4 weeks. In addition, participants will receive the standardized multimodal rehabilitation program consisting of 30 minutes of Bobath-based exercises, 10 minutes of neuromuscular electrical stimulation (NMES) applied to the hemiparetic limb, and 10 minutes of bicycle ergometer training.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Prospective Paralel Group Comparison Study
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
nclusion Criteria: Hemiparesis secondary to a prior stroke At least 6 months post-stroke Standardized Mini-Mental Test (SMMT) score between 18 and 23 Absence of visual impairment Ability to walk independently or with an assistive device Age between 65 and 85 years
Exclusion criteria
Contractures in joints of the hemiparetic extremity Peripheral nerve lesions or lower motor neuron disease Other neurological conditions such as ataxia, dyskinesia, or dystonia Uncontrolled hypertension Cardiac instability Any condition that could pose a risk during physical rehabilitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| "Single Leg Stance Test (SLST)" | Baseline and after 4 weeks of rehabilitation | For the test, volunteers were asked to lift one foot without touching the support leg, look steadily across, and maintain their balance for 30 seconds. The time they focused on the paretic limb for hemiparetic individuals and the time they focused on the dominant limbs for healthy individuals were recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) | Baseline and after 4 weeks of rehabilitation | The Berg Balance Scale (BBS) was used to assess functional balance. The scale consists of 14 items assessing balance during functional tasks. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 56. Higher scores indicate better balance performance. |
| TechnoBody Balance Test | Baseline and after 4 weeks of rehabilitation | The TechnoBody balance platform was used to assess postural balance. The system measures center-of-pressure displacement over time. Parameters including anteroposterior and mediolateral displacement, sway area, oscillation velocity, and total displacement distance were evaluated. |
| Functional Reach Test (FRT) | Baseline and after 4 weeks of rehabilitation | The Functional Reach Test (FRT) was used to assess dynamic balance. Functional reach distance was measured in centimeters. Distances of ≥25 cm indicate good balance, 16-24 cm indicate moderate impairment, and ≤15 cm indicate a high risk of instability. |
| Trunk Impairment Scale (TIS) | Baseline and after 4 weeks of rehabilitation | The Trunk Impairment Scale (TIS) was used to assess trunk control in participants with stroke. The total score ranges from 0 to 23, with higher scores indicating better trunk control. |
| 5-Repetition Sit-to-Stand Test (SST) | Baseline and after 4 weeks of rehabilitation | The 5-Repetition Sit-to-Stand Test (SST) was used to assess functional lower-extremity performance. Participants were instructed to stand up from and sit down on a chair five times as quickly as possible. The time required to complete five repetitions was recorded in seconds. A shorter completion time indicates better functional performance. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORNaziye Şenyuva Ceyhan
Istanbul University Cerrapasa
Outcome results
None listed