Beretta et al.

(2018)

Italy

PCT

N=41

Population:  robotically-driven orthoses (RDO) Group (N=29): Mean Age=11.2yr; Gender: Male=62%, Female=38%; Mean time post injury=2.6yr; Median GCS=6. Conventional therapy (CT) Group (N=12): Mean Age=11.92yr; Gender: Male=58%, Female=42%; Mean time post injury=2yr; Median GCS=5.

Intervention: 2 cohorts of children with severe TBI were the RDO group or CT group. The RDO group underwent Lokomat (robotic assisted gait training) for 20 sessions and CT for 20 sessions, whereas the CT group received 40 sessions of CT. Sessions were 45 min/d and 5 days a week for 4 weeks. Evaluated pre and post-therapy.

Outcome Measures: Gross motor function classification system (GMFCS), Disability rating scale (DRS), Functional Assessment questionnaire (FAQ), and the 6-min walk test (6MWT), 3-D gait analysis (including stance, cadence, step length, step symmetry, velocity, stride length, stride symmetry, step width).

1.        GMFCS subscores of standing and walking (D & E) were significantly different between groups (p<0.05) showing higher scores in the RDO group.

2.        Other measures were not significantly different between groups post-therapy (p>0.05)

3.        All measures in both groups (except FAQ in CT group) showed significant improvement (p<0.05) from pre to post evaluation.

4.        For the gait analysis, velocity was the only measure that showed significant between group difference (p<0.05) showing higher scores in the RDO group. However, scores for this measure did not significantly change within group.

5.        Stance (% stride) in the unaffected side, step length in the unaffected side, and stride length in the unaffected side showed significant improvement within the RDO group (p<0.05).

Only stride symmetry showed significant within-group improvement in the CT group.

Chen et al.

(2018)

USA

Pre-Post

N=10

Population:  TBI Group (N=10): Mean Age=13yr (3.9); Gender: Male=30%, Female=70%; Mean time post injury=45.7 days.

Intervention: A wearable ankle rehab robot with a computer game interface was used to aid acute rehab of TBI children. Therapy was conducted 3-5 times a week until 15 sessions had been complete, along with conventional therapy. Participants were evaluated pre and post-therapy, and at 6-weeks post (of which only 5 were able to attend).

Outcome Measures: Modified Ashworth Scale (MAS) for spasticity, Pediatric Balance scale (PBS), Selective control assessment of the lower extremity (SCALE), Fugl-meyer lower extremity (FMLE), 6 min walk test (6MWT), timed up and go (TUG), and 10m walk test (10MWT). Biomechanical measured from the device were active range of motion (AROM), passive ROM (PROM), and dorsiflexion & plantar flexion Maximal voluntary contraction (MVC)

1.        The MAS and PBS showed significant improvement pre to post evaluation (p=0.004 and p=0.038, respectively).

2.        The plantarflexion MVC showed improvement from post-therapy to 6-week follow-up (p=0.012)

3.        No other measures showed significant improvement (p>0.05)

Beretta et al.

(2015)

Italy

PCT

N=23

Population: ABI: TBI=11, Tumor=7, Ictus=4, Anoxia=1; Robotic-Aided Gait Training Group (RAGT; n=23): Mean Age=11.8 yr; Gender: Male=12, Female=11. Control Group (n=11): Mean Age=10.4 yr; Gender: Male=7, Female=4.

Intervention: Patients assigned to the RAGT group were provided with the use of an exoskeleton designed to perform a walking pattern on a treadmill, in addition to 20 sessions of physiotherapy. RAGT was performed for 45 min/d, 5 days/wk over 4 wk. The control group received physiotherapy only. Assessments were conducted at baseline and post-treatment.

Outcome Measure: 6-Min Walk Test (6MWT), Gross Motor Function Measure (GMFM), Functional Assessment Questionnaire (FAQ), 3D Gait Analysis.

1.        The RAGT group improved significantly in overall gross motor function on the GMFM (p<0.001). Specific improvements were found on the subscales of GMFM for lying/rolling and crawling/kneeling (both p<0.010) and standing and walking (both p<0.001).

2.        There were significant improvements in walking ability on the FAQ in the RAGT group (p<0.010).

3.        The control group improved significantly on the GMFM dimension C subscale (crawling and kneeling) only from baseline to post-treatment (p<0.010).

4.        Subgroup analyses of ambulant patients revealed that the RAGT group improved significantly on the FAQ (p=0.007), 6MWT (p<0.005), GMFW Dimension C (p=0.006) D and E (both p=0.001) whereas control patients only improved significantly on the GMFW Dimension C (p<0.050).

3D Gait Analysis of ambulant patients revealed that the RAGT group improved significantly in cadence, left-side step-length, velocity, ROM hip flex-extension during gait and swing, and maximum hip extension left-side stride length (all p<0.050) and right-side stride length (p<0.005) from baseline to post-treatment. The control group did not demonstrate any significant improvements.

Frascarelli et al.

(2009)

Italy

Pre-Post

N=12

Population: TBI=6, Stroke=4, Cerebral Palsy=2; Mean Age =11.7 yr; Gender: Male=9, Female=3; Mean Time Since Injury=3.5 yr.

Intervention: Robot Mediated Therapy (RMT) for upper limb was combined with goal-oriented reaching tasks for 1 hr 3x/wk over a period of 6 wk. Outcome measures were assessed at baseline and 6 wk.

Outcome Measure: Modified Ashworth Scale (MAS), Fugl-Meyer (FM), The Melbourne Assessment of Unilateral Upper Limb (Melbourne%), Reaching Performance Scale (RPS) close and far, Jerk Metric (JM), and Average Speed.

1.        There was a significant improvement in MAS (p=0.001), FM (p=0.002), Melbourne% (p<0.001), JM (p=0.006) and average speed (p=0.010) from baseline to 6 wk.

2.        There was a significant improvement from baseline to 6 wk follow-up in RPS at close and far distances (p=0.004 and p=0.032, respectively).