Moattari et al. (2016)

Iran

RCT

PEDro=8

N=60

Population: TBI; Mean Age=37 yr; Gender: Male=50, Female=10; Mean GCS=6.

Intervention: Participants in a coma were randomized to receive standard care (control, n=20) or a sensory stimulation program (treatment) from a qualified nurse (n=20) or a family member (n=20). The program involved awakening (5 min), auditory (10 min), visual (10 min), tactile (5 min), and olfactory (10 sec) stimulation 2x/ day for 7 days. Outcomes were assessed daily over 7 days.

Outcome Measures: Glasgow Coma Scale (GCS), Rancho Los Amigos Scale (RLAS), Western Neurosensory Stimulation Profile (WNSSP).

1.        Mean GCS scores were significantly higher in the family group than in the nurse and control groups at 6 days (8.85 versus 7.15 versus 6.60, p=0.035) and 7 days (9.20 versus 7.15 versus 6.70, p=0.001).

2.        Mean RLAS scores were significantly higher in the family group than in the nurse and control groups at 5 days (2.60 versus 2.15 versus 2.10, p=0.006), 6 days (2.95 versus 2.15 versus 2.15, p=0.001), and 7 days (3.10 versus 2.15 versus 2.15, p=0.001).

3.        Mean WNSSP scores were significantly higher in the family group than in the nurse and control groups at 4 days (17.55 versus 11.05 versus 11.15, p=0.03), 5 days (28.15 versus 15.45 versus 14.75, p=0.003), 6 days (44.75 versus 17.65 versus 14.45, p=0.001), and 7 days (50.35 versus 18.4 versus 14.55, p=0.001).

4.        The family group showed significant improvements on GCS (p=0.001), RLAS (p<0.01), and WNSSP (p=0.001) in separate comparisons to the nurse group and controls.

5.        The nurse group showed significant improvements on WNSSP (p=0.002), but not GCS (p=0.98) or RLAS (p=0.38)  when compared to controls.

Tavangar et al. (2015)

Iran

RCT

PEDro=7

N=40

Population: ABI; Mean Age=36 yr; Mean GCS=6.

Intervention: Participants in a coma were randomized to receive standard care (control, n=20) or auditory stimulation (treatment, n=20). Stimulation involved listening to 5-1 5 min voice recordings of a family member 2 x/day for 10 days.

Outcome Measure: Glasgow Coma Scale (GCS).

1.        Mean GCS significantly improved in both groups after 10 days (p=0.0001).

1.        Mean GCS at 10 days was significantly higher in the treatment group than in controls (10.25 versus 7.75, p=0.0001).

Gorji et al. (2014b)

Iran

RCT

PEDro=5

N=13

Population: TBI; GCS Range≤8.

Intervention: Patients were randomly assigned to receive standard care (control) or listen to a 10-minvoice recording of a “loved one”2x/ day for 2 wk (treatment).

Outcome Measure: Coma Duration.

Megha et al. (2013)

India

RCT

PEDro=6

N=30

Population: TBI; Treatment Group 1 (TG1, n=10): Mean Age=35 yr; Mean Time Post Injury=7.8 days; Mean GCS=3.4. Treatment Group 2 (TG2, n=10): Mean Age=40.9 yr; Mean Time Post Injury=7.8 days; Mean GCS=3.5. Control Group (CG, n=10): Mean Age=43.2 yr; Mean Time Post Injury=7.5 days; Mean GCS=3.4.

Intervention: Participants in a coma were randomly assigned to receive conventional physiotherapy (CG) or multimodal stimulation for 2 wk. Stimulation was delivered in 20 min sessions 5x/ days (TG1) or 50 min sessions 2x/ days (TG2). Outcomes were assessed before and after treatment.

Outcome Measures: Glasgow Coma Scale (GCS), Western Neuro Sensory Stimulation Profile (WNSSP).

1.        GCS significantly improved in TG1 (z=2.821, p=0.005), TG2 (z=2.848, p=0.004), and CG (z=2.724, p=0.006) after treatment.

2.        WNSSP significantly improved in TG1 (z=2.809, p=0.005), TG2 (z=2.807, p=0.005), and CG (z=2.812, p=0.005) after treatment.

3.        After treatment, there were significant overall differences between groups in GCS (χ²=9.516, p=0.009) and WNSSP (χ²=17.136, p<0.001).

4.        GCS after treatment was significantly higher in TG1 (U=14, p=0.005) than in CG. GCS was higher in TG2 than CG (U=19, p=0.019) and in TG1 than TG2 (U=42.5, p=0.579), but these differences were not significant.

5.        WNSSP after treatment was significantly higher in TG1 than TG2 (U=14.5, p=0.005) and CG (U=6, p<0.001), and in TG2 than CG (U=11, p=0.002).

Abbasi et al. (2009)

Iran

RCT

PEDro=7

N=50

Population: ABI; Treatment Group (n=25): Mean Age=30.4 yr; Gender: Male=22, Female=3; Mean GCS=7.0. Control Group (n=25): Mean Age=30.4 yr; Gender: Male=21, Female=4; Mean GCS=6.9.

Intervention: Participants were randomized to receive either a regular family visiting program (treatment) or routine care (control).  Family visits were 15 min for 6 days and were structured to include affective, auditory, and tactile stimulation. Outcomes were assessed at baseline and 30min after each visit.

Outcome Measure: Glasgow Coma Scale (GCS).

1.        The treatment group showed significant increases in GCS scores on each day during the study period (p<0.05).

2.        After 6 days, GCS scores in the treatment group were significantly higher than in the control group (8.8 versus 6.8, p=0.0001).

Johnson et al. (1993)

UK

RCT

PEDro=3

N=14

Population: ABI; Treatment Group (TG, n=7): Mean Age=27.7 yr; Time Post Injury<48 hr; Mean GCS=4.8. Control Group (CG, n=7): Mean Age=31.4 yr; Time Post Injury<48 hr; Mean GCS=4.8.

Intervention: Participants were randomized to receive sensory stimulation (TG) or no stimulation (CG). Treatment involved stimulation of the five senses (olfactory, visual, auditory, gustatory, and tactile) for 20 min/ day during ICU stay.

Outcome Measures: Physiological parameters (heart rate, skin conductance), Biochemical parameters (Methoxy-4-Hydroxyphenylglycol (MHPG), Acetylcholinesterase (ACHE), Catecholamine, Serotonin).

1.        MHPG levels were significantly higher in the TG than CG post treatment (F=8.54, p<0.006).

2.        No significant group differences post treatment were seen in heart rate (F=0.70, p<0.499) or skin conductance (F=2.51, p<0.092), nor for levels of catecholamine, serotonin, or ACHE.

Park et al. (2016)

Korea & USA

Pre-Post

N=9

Population: TBI; Mean Age=29.7 yr; Gender: Male=9, Female=0; Mean GCS=5.88; Mean SSAM=3.44.

Intervention: Comatose patients underwent both direct, and non-direct auditory stimulation in random order (15 min each, 1 hr between treatments).

Outcome Measures: Glasgow Coma Scale (GCS), Sensory Stimulation Assessment Measure (SSAM).

1.        GCS and SSAM scores were significantly increased above baseline after exposure to direct and non-direct auditory stimulation (both p=0.008).

2.        Compared to non-direct auditory stimulation, SSAM scores improved significantly more after direct stimulation (p=0.021).

Di Stefano et al. (2012)

Italy

Case Series

N=12

Population: TBI; Mean Age=30.75 yr; Gender: Male=7, Female=5; Mean Time Post Injury=5.75 mo.

Intervention: Participants in a vegetative state (VERSUS, n=6) or minimally conscious state (MCS, n=6) received sensory stimulation based on biographically meaningful objects. The order of phases were: Hygienic Care (H1), Cognitive Stimulation (CS1), Enriched Stimulation (ES), Cognitive Stimulation (CS2), and Hygienic Care (H2).

Outcome Measures: Wessex Head Injury Matrix (WHIM) – Number of Behaviours (NB) and Best Behaviours (BB).

1.        NB was statistically greater in the ES phase (p<0.01).

2.        There was no significant difference in NB between H1 and H2 (p>0.05) or CS1 and CS2 (p>0.05).

3.        There was no significant difference in NB between VERSUS patients and MCS patients (p>0.05).

4.        The BB was observed in the ES phase for all 12 patients.

Urbenjaphol et al. (2009)

Thailand

PCT

N=40

Population: TBI; Mean Age=34 yr; Gender: Male=28, Female=12; Mean Time Post Injury=7 days; Mean GCS=5.

Intervention: Participants received standard care (control, n=20) or a multimodal sensory stimulation program (treatment, n=20). The program involved tactile, gustatory, olfactory, auditory, and visual stimulation. Each modality was stimulated for 30m in/day at 2 hr intervals over 14 days.

Outcome Measures: Glasgow Coma Scale (GCS), Sensory Modality Assessment & Rehabilitation Technique (SMART).

1.        Mean GCS scores were significantly higher in the treatment group than in controls at 14 days (10.45 versus 5.9, p<0.05).

2.        Mean SMART scores were significantly higher in the treatment group than in controls at 14 days (14.76 versus 8.72, p<0.05).

Davis & Gimenez (2003)

USA

PCT

N=12

Population: TBI; Treatment Group (n=9): Mean Age=30 yr; Mean Time Post Injury=9 days; Mean GCS=5.5. Control Group (n=3): ­Mean Age=30 yr; Mean Time Post Injury=6 days; Mean GCS=6.

Intervention: Participants received either a structured auditory sensory stimulation program (treatment) or no stimulation (control). Stimulation included:  orientation and commands, bells, blocks and claps, music, familiar voices, and television or radio. Participants received stimulation 5-8x/d for 5-15min each up to 7d days.

Outcome Measures: Glasgow Coma Scale (GCS), Disability Rating Scale (DRS), Ranchos Los Amigos Scale (RLAS), Sensory Stimulation Assessment Measure (SSAM).

1.        Mean change in GCS score was not significantly different between groups (p=0.278). However, GCS were lower in the treatment group and increased over time, while they were higher in the control group and decreased over time.

2.        Mean change in DRS score was significantly greater in the treatment group than the control group (2.7 versus 0.3, p=0.0005).

3.        Mean change in SSAM score was significantly greater in the treatment group than the control group (11 versus 0.3, p=0.015).

4.        Mean change in RLAS score was 1.2 in the treatment group, while there was no change in the control group.

Gruner & Terhaag (2000)

Germany

Pre-Post

N=16

Population: ABI; Mean Age=43.6 yr; Mean Time Post Injury=28 days; Mean GCS=6.5.

Intervention: Participants received multimodal early onset stimulation (MEOS) for 1 hr, 2x/day for 10 days (1-30 days). MEOS involved acoustic, tactile, olfactory, gustatory, and kinesthetic stimulation.

Outcome Measures: Physiological parameters (cardiovascular and respiratory).

1.        Changes in heart and respiratory frequencies were noted; the most significant changes were found following tactile and acoustic stimulation.

2.        No statistical comparisons were reported.

Wilson et al. (1996)

UK

Pre-Post

N=24

1.        Frequency with which eyes were observed opened increased significantly following multimodal (p<0.001) and multimodal familiar (p<0.05) stimulation; no significant changes were seen following unimodal stimulation.

2.        Significant increases in the frequency of spontaneous movements with eyes opened following multimodal (p<0.005), unimodal (p<0.05) and multimodal familiar stimulation (p<0.05).

3.        There was a significant decrease in the frequency of eyes shut with no body movement following both multimodal (p<0.005) and multimodal familiar stimulation (p<0.05).

4.        There was a significant reduction in reflexive movements with eyes shut following multimodal stimulation (p<0.025).

Hall et al. (1992)

Canada

PCT

N=6

Population: TBI; Mean Age=37.5yr; Gender: Male=5, Female=1; Mean Time Post Injury=15.8d; Mean GCS=4.8.

Intervention: Participants were alternated every week between either specific directed stimulation (SDS), or non-directed stimulation (NDS), each for 30 min/day, for the duration of the treatment period. SDS involved multisensory input based on level of response, while NDS did not.

Outcome Measures: Glasgow Coma Scale (GCS), Rancho Los Amigos Scale (RLAS), Western Neuro Sensory Stimulation Profile (WNSSP), Sensory Stimulation Assessment Measure (SSAM).

1.        General improvement on the GCS and RLAS was seen over the course of the treatment for both conditions.

2.        General improvement on the WNSSP was seen over the course of the treatment for both conditions, with improvement from 20% to 80%.

3.        Subjects obtained higher SSAM scores for eye movements during the SDS condition than during the NDS condition.

Wood et al. (1992)

USA

PCT

N=8

Population: ABI; Mean Age=23.3 yr; Mean Time Post Injury=56.5 days; Mean GCS=9.5.

Intervention: Participants received intensive regulated sensory stimulation (treatment, n=4) or standard unregulated stimulation (control, n=4). Treatment involved sensory stimulation with low ambient noises, regular rest intervals free from stimulation, and appropriate inter-stimulus intervals during therapy.

Outcome Measures: Glasgow Coma Scale (GCS), Rancho Los Amigos Scale (RLAS), Length of Stay (LOS).

1.        Mean LOS was shorter in the treatment group than the control group (88.7 days versus 125.7 days).

2.        The treatment group made greater progress on GCS and RLAS scores than the control group.

3.        All patients in the treatment group progressed into an acute rehab setting compared with only one of the control patients.

4.        No statistical comparisons were reported.

Kater (1989)

USA

PCT

N=30

Population: ABI; Mean Age=28yr; Gender: Male=18, Female=12; Time Post Injury<6 mo.

Intervention: Participants received controlled structured sensory stimulation (treatment, n=15) or standard care (control, n=15). Treatment involved visual, auditory, olfactory, gustatory, tactile, and kinesthetic stimulation for 45min, 2x/d,  6d/wk for 1-3 mo.

Outcome Measure: Rancho Los Amigos Scale (RLAS).

1.        Patients in the treatment group had a significantly improved mean RLAS score compared with controls (6.33 versus 4.40, p<0.05); RLAS was inversely correlated with initial GCS.

2.        Subjects with moderate and deep coma (GCS=3-10) benefitted more from treatment, while subjects with light coma severity (GCS=11-14) showed little difference from the controls.

3.        Subjects from enriched environments showed significant improvement compared with subjects from non-enriched environments (t=2.20, p<0.05).

Mitchell et al. (1990)

UK

PCT

N=24

Population: ABI; Mean Age=23yr; Gender: Male=20, Female=4; Mean Time Post Injury=8d; Mean GCS=5.

Intervention: Participants received a multisensory stimulation program (treatment, n=12) or standard care (control, n=12). The program involved vigorous stimulation of auditory, tactile, olfactory, gustatory, visual, kinesthetic, proprioceptive, and vestibular modalities in a cyclical manner for 1hr, 1-2x/d over 4 days.

Outcome Measures:  Glasgow Coma Scale (GCS), Coma Duration.

1.        Mean GCS increased more rapidly in the treatment group.

2.        Mean coma duration for the treatment group was significantly shorter than for controls (22d versus 27d, p<0.05).

Pierce et al. (1990)

USA

Case Control

N=31

Population: ABI; Mean Age=24 yr; Gender: Male=21, Female=10; GCS Range<6.

Intervention: Participants received vigorous multisensory stimulation (auditory, vestibular, visual and cutaneous) provided by close family for up to 8 hr/day and 7 days/wk, continuing until conventional rehabilitation. The control group was composed of a historical group of consecutive patients in prolonged coma (n=135). Outcomes were assessed 10-12 mo post injury. Outcome Measures: Coma Duration, Glasgow Outcome Scale (GOS).

1.        The number patients who emerged from the coma did not differ significantly between groups.

2.        No significant improvements were noted between groups in GOS scores (p>0.25).

3.        No significant differences were found in reasonable recovery rate between treatment and control groups (42% versus 31%, p>0.025).