Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Fall Prevention and Locomotion Recovery in Post-stroke Patients: A Multimodal Training
Brief Summary: The study proposes a novel rehabilitative program for the recovery of locomotor abilities in post-acute stroke patients. The hypothesis is that a rehabilitative program which involves a biofeedback cycling training combining voluntary effort and Functional Electrical Stimulation (FES) of the leg muscles, and a biofeedback balance training is superior to usual care in improving walking abilities, disability, motor performance, and independence of post-acute stroke patients. The innovative approach is to investigate whether interventions which do not directly involve locomotor functions but movements similar in terms of kinematic patterns and neural commands (e.g. pedaling), or aimed at recovering an essential prerequisite for walking, such as postural control during upright stance, may improve and/or accelerate the recovery of walking abilities.

A single-blind randomized controlled study is carried out. Participants are post-acute stroke patients experiencing a first stroke less than 6 months before recruitment, with an adult age, a low level of spasticity of the leg muscles (Modified Ashworth scale \<2), no limitations at hip, knee, and ankle joints, and able to sit up to 30 minutes. Subjects are randomized to one of two groups, one performing the novel rehabilitative program in addition to usual care (experimental group), and one performing usual care alone (control group).

The experimental program consists of 15 sessions of FES-supported voluntary cycling training followed by 15 sessions of balance training. Both cycling and balance training are supported by a visual biofeedback in order to maximize patients' involvement in the exercise and are performed in addition to usual care.

The control group is involved in standard physical therapy which includes stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation.

Both training programs last 6 weeks and patients are trained daily for about 90 minutes. Cycling and balance training last about 20 minutes; thus, patients in the experimental group perform only about 70 minutes of usual care.

Participants are evaluated at baseline (T1), after the end of the cycling training or after 3 weeks of usual care (post-treatment, T2), after the end of the whole intervention (post-treatment, T3), and about 6 months after the end of the intervention (follow-up, T4).


Options:
A: Arm Label: Biofeedback training; Type: EXPERIMENTAL; Interventions: Device: Cycling, Device: Balance, Other: Standard physical therapy | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard physical therapy | Intervention Type: DEVICE; Name: Cycling; Assigned to Arm(s): Biofeedback training | Intervention Type: DEVICE; Name: Balance; Assigned to Arm(s): Biofeedback training | Intervention Type: OTHER; Name: Standard physical therapy; Assigned to Arm(s): Biofeedback training, Usual Care
B: Intervention Type: BEHAVIORAL; Name: Conventional UK Physical therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Increased intensity of UK conventional physical therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: UK conventional physical therapy plus functional strength training; Assigned to Arm(s): N/A
C: Arm Label: tDCS + physical therapy; Type: EXPERIMENTAL; Interventions: Device: tDCS + physical therapy | Arm Label: Sham tDCS + physical therapy; Type: SHAM_COMPARATOR; Interventions: Device: tDCS + physical therapy | Intervention Type: DEVICE; Name: tDCS + physical therapy; Assigned to Arm(s): Sham tDCS + physical therapy, tDCS + physical therapy
D: Arm Label: Arm A Anodal tDCS and prismatic adaptation; Type: EXPERIMENTAL; Interventions: Device: transcranial direct current stimulation (tDCS) | Arm Label: Arm B: control; Type: PLACEBO_COMPARATOR; Interventions: Device: Control: placebo stimulation | Intervention Type: DEVICE; Name: transcranial direct current stimulation (tDCS); Assigned to Arm(s): Arm A Anodal tDCS and prismatic adaptation | Intervention Type: DEVICE; Name: Control: placebo stimulation; Assigned to Arm(s): Arm B: control

Answer: A